TMJ SYSTEM 24-6546TIRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841036081713), received between Dec 6, 2019 and Aug 31, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TMJ ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A TMJ-PMI INLAY PRODUCT ON AN UNKNOWN DATE DUE TO STRONG PAIN ON THE LEFT SIDE. THE SURGEON IS REQUESTING AN OVERLAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 17667608 ↗
• InjuryDec 13, 2022Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN, VERTIGO, MISALIGNMENT, AND HER BITE IS OFF. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain; Vertigo

  MAUDE report 15969727 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Information

  MAUDE report 10856786 ↗
• InjuryJul 13, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN FOLLOWING IMPLANTATION OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS TWO (2) YEARS AGO. THE PATIENT REPORTS THAT THE IMPLANTS ARE SITTING INCORRECTLY IN THE CONDYLES OF THE PATIENT¿S FACE, ARE SITTING TOO FAR BACK, AND ARE PRESSING ON THE EAR CANAL. THE PATIENT IS RECEIVING BOTOX FOR PAIN MANAGEMENT. THERE IS NO REVISION PLANNED AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Pain

  MAUDE report 10267057 ↗
• InjuryDec 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: No Information

  MAUDE report 9428524 ↗

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-0520-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
• Z-0522-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Rt Standard 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-0513-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the temporomandibular joint
• 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-0509-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
• Z-0514-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off 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-0511-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Rt Narrow 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-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-0519-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 55mm 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.