Introduction: Temporomandibular disorder (TMD) is a common, yet potentially debilitating syndrome that negatively impacts patient quality of life. In patients with severe variants of TMD, temporomandibular joint (TMJ) devices have been utilized to replace the joint altogether. However, the risk profile and consequent cost-benefit ratio of these devices are largely debated. This report aimed to provide further insight on the safety of surgically implanted TMJ devices by analyzing adverse events from the Manufacturer and User Facility Device Experience (MAUDE) database. Methods: Inclusion criteria consisted of all MAUDE reports from January 2013 to January 2023 containing the keyword “TMJ.” Duplicate reports, preimplantation events, reports extrapolated from published literature reviews, and those not related to TMJ implants were excluded from analysis. Adverse events were extracted, reviewed, and categorized according to complication type, management strategy, device manufacturer, causes of device malfunction, and reporting timeframe. Nonparametric χ2 and Levene’s test were used to compare average values between groups with a two-tailed p value of 0.05 being considered statistically significant. Results: A total of 385 adverse event reports were reviewed. The most common complications were infection (59, 25.9%), ankylosis (57, 25.0%), and pain (33, 14.5%). The most common device failures were implant malposition (28, 39.4%), implant dislodgement (22, 31.0%), and screw osseointegration failure (11, 15.5%). Upon assessment of revision surgeries, those undertaken to address infections had the highest rate of device explantation (77%). In a separate analysis of 28 adverse events submitted directly by patients, infection was most common self-reported complication (42.9%). Comparison of device manufacturers revealed that Biomet implants had significantly more reports of pain (χ2 = 10.21, p = 0.003), whereas Stryker implants had more infections (χ2 = 29.87, p < 0.001). Conclusion: In summary, this in-depth analysis of adverse events provides a safety profile of TMJ implants. Understanding the complication types, management strategies, and outcomes according to device manufacturer may help set patient expectations and improve patient care.

1.
Mercuri
LG
.
The use of alloplastic prostheses for temporomandibular joint reconstruction
.
J Oral Maxillofac Surg
.
2000
;
58
(
1
):
70
5
.
2.
Price
AJ
,
Alvand
A
,
Troelsen
A
,
Katz
JN
,
Hooper
G
,
Gray
A
, et al
.
Knee replacement
.
Lancet
.
2018
;
392
(
10158
):
1672
82
.
3.
Giannakopoulos
HE
,
Sinn
DP
,
Quinn
PD
.
Biomet microfixation temporomandibular joint replacement system: a 3-year follow-up study of patients treated during 1995 to 2005
.
J Oral Maxillofac Surg
.
2012
;
70
(
4
):
787
96
; discussion 95-6.
4.
Burgess
M
,
Bowler
M
,
Jones
R
,
Hase
M
,
Murdoch
B
.
Improved outcomes after alloplastic TMJ replacement: analysis of a multicenter study from Australia and New Zealand
.
J Oral Maxillofac Surg
.
2014
;
72
(
7
):
1251
7
.
5.
Sanovich
R
,
Mehta
U
,
Abramowicz
S
,
Widmer
C
,
Dolwick
MF
.
Total alloplastic temporomandibular joint reconstruction using Biomet stock prostheses: the University of Florida experience
.
Int J Oral Maxillofac Surg
.
2014
;
43
(
9
):
1091
5
.
6.
Speculand
B
.
Current status of replacement of the temporomandibular joint in the United Kingdom
.
Br J Oral Maxillofac Surg
.
2009
;
47
(
1
):
37
41
.
7.
Dimitroulis
G
.
Comparison of the outcomes of three surgical treatments for end-stage temporomandibular joint disease
.
Int J Oral Maxillofac Surg
.
2014
;
43
(
8
):
980
9
.
8.
Gonzalez-Perez
LM
,
Fakih-Gomez
N
,
Gonzalez-Perez-Somarriba
B
,
Centeno
G
,
Montes-Carmona
JF
.
Two-year prospective study of outcomes following total temporomandibular joint replacement
.
Int J Oral Maxillofac Surg
.
2016
;
45
(
1
):
78
84
.
9.
Johnson
NR
,
Roberts
MJ
,
Doi
SA
,
Batstone
MD
.
Total temporomandibular joint replacement prostheses: a systematic review and bias-adjusted meta-analysis
.
Int J Oral Maxillofac Surg
.
2017
;
46
(
1
):
86
92
.
10.
Dimitroulis
G
,
Austin
S
,
Sin Lee
PV
,
Ackland
D
.
A new three-dimensional, print-on-demand temporomandibular prosthetic total joint replacement system: preliminary outcomes
.
J Cranio-Maxillo-Fac Surg
.
2018
;
46
(
8
):
1192
8
.
11.
Sahdev
R
,
Wu
BW
,
Anderson
N
,
Khawaja
SN
,
Kim
S
,
Keith
DA
.
A retrospective study of patient outcomes after temporomandibular joint replacement with alloplastic total joint prosthesis at Massachusetts general hospital
.
J Oral Maxillofac Surg
.
2019
;
77
(
2
):
280
8
.
12.
Mercuri
LG
,
Wolford
LM
,
Sanders
B
,
White
RD
,
Giobbie-Hurder
A
.
Long-term follow-up of the CAD/CAM patient fitted total temporomandibular joint reconstruction system
.
J Oral Maxillofac Surg
.
2002
;
60
(
12
):
1440
8
.
13.
Mercuri
LG
,
Edibam
NR
,
Giobbie-Hurder
A
.
Fourteen-year follow-up of a patient-fitted total temporomandibular joint reconstruction system
.
J Oral Maxillofac Surg
.
2007
;
65
(
6
):
1140
8
.
14.
Amarista
FJ
,
Mercuri
LG
,
Perez
D
.
Temporomandibular joint prosthesis revision and/or replacement survey and review of the literature
.
J Oral Maxillofac Surg
.
2020
;
78
(
10
):
1692
703
.
15.
Granquist
EJ
,
Bouloux
G
,
Dattilo
D
,
Gonzalez
O
,
Louis
PJ
,
McCain
J
, et al
.
Outcomes and survivorship of Biomet microfixation total joint replacement system: results from an FDA postmarket study
.
J Oral Maxillofac Surg
.
2020
;
78
(
9
):
1499
508
.
16.
Bestourous
DE
,
Pasick
LJ
,
Benito
DA
,
Zapanta
PE
.
Adverse events associated with the Inspire implantable hypoglossal nerve stimulator: a MAUDE database review
.
Am J Otolaryngol
.
2020
;
41
(
6
):
102616
.
17.
Hur
K
,
Ge
M
,
Kim
J
,
Ference
EH
.
Adverse events associated with balloon sinuplasty: a MAUDE database analysis
.
Otolaryngol Head Neck Surg
.
2020
;
162
(
1
):
137
41
.
18.
Reyes Orozco
F
,
Ulloa
R
,
Lin
M
,
Xepoleas
M
,
Paoletti
M
,
Liu
X
, et al
.
Adverse events associated with image-guided sinus navigation in endoscopic sinus surgery: a MAUDE database analysis
.
Otolaryngol Head Neck Surg
.
2023
;
168
(
3
):
501
5
.
19.
Covert
L
,
Mater
HV
,
Hechler
BL
.
Comprehensive management of rheumatic diseases affecting the temporomandibular joint
.
Diagnostics
.
2021
;
11
(
3
):
409
.
20.
Bitiniene
D
,
Zamaliauskiene
R
,
Kubilius
R
,
Leketas
M
,
Gailius
T
,
Smirnovaite
K
.
Quality of life in patients with temporomandibular disorders. A systematic review
.
Stomatologija
.
2018
;
20
(
1
):
3
9
.
21.
Mercuri
LG
.
Prevention and detection of prosthetic temporomandibular joint infections-update
.
Int J Oral Maxillofac Surg
.
2019
;
48
(
2
):
217
24
.
22.
Povolotskiy
R
,
Abraham
ME
,
Leverant
AB
,
Bresler
A
,
Paskhover
B
.
Complications of Palatal Pillar Implants: an analysis of the MAUDE database and literature review
.
Am J Otolaryngol
.
2020
;
41
(
1
):
102303
.
23.
Bestourous
DE
,
Davidson
L
,
Reilly
BK
.
A review of reported adverse events in MRI-safe and MRI-conditional cochlear implants
.
Otol Neurotol
.
2022
;
43
(
1
):
42
7
.
24.
Leandro
LF
,
Ono
HY
,
Loureiro
CC
,
Marinho
K
,
Guevara
HA
.
A ten-year experience and follow-up of three hundred patients fitted with the Biomet/Lorenz Microfixation TMJ replacement system
.
Int J Oral Maxillofac Surg
.
2013
;
42
(
8
):
1007
13
.
25.
Bach
E
,
Sigaux
N
,
Fauvernier
M
,
Cousin
AS
.
Reasons for failure of total temporomandibular joint replacement: a systematic review and meta-analysis
.
Int J Oral Maxillofac Surg
.
2022
;
51
(
8
):
1059
68
.
26.
Zou
L
,
He
D
,
Ellis
E
.
A comparison of clinical follow-up of different total temporomandibular joint replacement prostheses: a systematic review and meta-analysis
.
J Oral Maxillofac Surg
.
2018
;
76
(
2
):
294
303
.
27.
De Meurechy
NKG
,
Zaror
CE
,
Mommaerts
MY
.
Total temporomandibular joint replacement: stick to stock or optimization by customization
.
Craniomaxillofac Trauma Reconstr
.
2020
;
13
(
1
):
59
70
.
28.
Lee
J
,
Reichstein
J
,
Vance
I
,
Wild
D
.
Quality of capsule endoscopy reporting in patients referred for double balloon enteroscopy
.
Gastroenterology Res
.
2023
;
16
(
2
):
92
5
.
29.
Chen
S
,
He
Y
,
An
JG
,
Zhang
Y
.
Recurrence-related factors of temporomandibular joint ankylosis: a 10-year experience
.
J Oral Maxillofac Surg
.
2019
;
77
(
12
):
2512
21
.
30.
Roychoudhury
A
,
Yadav
P
,
Alagarsamy
R
,
Bhutia
O
,
Goswami
D
.
Outcome of stock total joint replacement with fat grafting in adult temporomandibular joint ankylosis patients
.
J Oral Maxillofac Surg
.
2021
;
79
(
1
):
75
87
.
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