TMJ SYSTEM 24-6555Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00841036060398), received between Mar 6, 2019 and Feb 2, 2026 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (1 report).

17 other recalls cover devices cleared under the same FDA submission (P020016); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Migration

  IT WAS REPORTED THAT A PATIENT WITH TEMPOROMANDIBULAR JOINT PROSTHESES EXPERIENCED RIGHT-SIDED IMPLANT SHIFTING WITH IMPINGEMENT TOWARD THE EAR CANAL. NO FURTHER INTERVENTION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234339 ↗
• InjuryMay 16, 2023Fitting Problem; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Fitting Problem; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT IS FURTHER REPORTED THAT THE EVENT WAS AN INITIAL PROCEDURE WITH THE SURGEON CHOOSING A DIFFERENT IMPLANT FOR FIT DURING THE INITIAL TMJ PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16938496 ↗
• MalfunctionApr 19, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 16768289 ↗
• InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN IN THE JAW AND EAR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 15106063 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Discomfort; Hearing Loss; Pain; Rupture

  MAUDE report 10777320 ↗
• InjuryMar 2, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WILL UNDERGO A REVISION OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS DUE TO THE DEVELOPMENT OF CERVICAL DYSTONIA. A REVISION IS PLANNED BUT HAS NOT YET OCCURRED. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Neurological Deficit/Dysfunction; Pain

  MAUDE report 9776497 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A BILATERAL REVISION OF TEMPOROMANDIBULAR JOINT PROSTHESES DUE TO AN UNKNOWN REASON. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9592384 ↗
• InjuryMay 22, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Information

  MAUDE report 8634388 ↗
• InjuryMay 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Pain; Swelling

  MAUDE report 8633978 ↗
• InjuryMar 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Bacterial Infection

  MAUDE report 8394434 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020016. One submission often covers many models, so check the product and lot details in each record.

• Z-0518-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the temporomandibular joint
• Z-0516-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand Reconstruction of the temporomandibular joint
• Z-0513-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the temporomandibular joint
• Z-0517-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
• Z-0514-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
• Z-0512-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint
• Z-0509-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
• Z-0522-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand Reconstruction of the temporomandibular joint
• Z-0519-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
• Z-0515-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
• Z-0520-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
• Z-0511-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
• Z-0510-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
• Z-0521-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
• Z-2566-2014 · Sep 20, 2013 · Terminated
  Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to

…and 2 more.