TMJ SYSTEM 24-6550Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00841036060343), received between Nov 29, 2018 and Jul 27, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Malposition of Device

  It was reported that approximately 2 years post-implantation the patient alleges the right implant was extending into the ear and causing hearing loss. Further, the patient described a sensation like cotton in the right ear with some discomfort but no pain. The patient is speaking with the surgeon, but no further intervention has been reported to date.Attempts have been made and no further information has been provided.

  Patient problems: Discomfort; Partial Hearing Loss

  MAUDE report 50036260 ↗
• InjurySep 8, 2025Fracture; Fracture

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL RIGHT TMJ PROCEDURE. THE PATIENT EXPERIENCED RIGHT FACIAL PAIN AND UNDERWENT A REVISION PROCEDURE APPROXIMATELY (4) YEARS POST-IMPLANTATION DUE TO IMPLANT FRACTURE. ALL FRAGMENTS OF THE MANDIBLE IMPLANT WERE REMOVED AND THE FOSSA COMPONENT WAS RETAINED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 22992029 ↗
• InjuryJul 27, 2022Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO AN UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15112341 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Extraskeletal ossification; Loss of Range of Motion; Pain

  MAUDE report 11405111 ↗
• InjuryDec 4, 2020Migration; Migration

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

  Patient problems: No Information

  MAUDE report 10944385 ↗
• InjuryJun 15, 2020Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

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

  Patient problems: Extraskeletal ossification; Pain

  MAUDE report 10152637 ↗
• InjuryJun 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A SCAR TISSUE REMOVAL PROCEDURE AND CURRENTLY UNDERGOES PAIN MANAGEMENT FOLLOWING IMPLANTATION OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS TWELVE YEARS AGO. THE PATIENT REPORTED A SCAR TISSUE REMOVAL PROCEDURE TWO (2) YEARS AGO. THE PATIENT ATTENDS A PAIN MANAGEMENT CONSULT EVERY SIX (6) TO EIGHT (8) WEEKS. THE PATIENT HAS PREVIOUSLY RECEIVED CORTISONE SHOTS AND IS CURRENTLY ON BOTOX SHOTS, CELEBREX AND OXYCODONE. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Inadequate Pain Relief; Pain; Scar Excision; Scar Tissue

  MAUDE report 10112021 ↗
• InjuryMar 30, 2020Adverse 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 9897171 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION OF TEMPOROMANDIBULAR JOINT IMPLANTS ON THE RIGHT SIDE DUE TO AN UNKNOWN REASON. STOCK MANDIBLE AND FOSSA IMPLANTS WERE REMOVED AND REPLACED WITH NEW STOCK IMPLANTS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9569679 ↗
• InjuryDec 6, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: No Information

  MAUDE report 9428388 ↗
• InjuryOct 10, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Difficulty Chewing; Pain; Sleep Dysfunction

  MAUDE report 9177298 ↗
• InjuryNov 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS PRESCRIBED FLEXERIL FOR THIRTY DAYS FOR HER PAIN IN HER LEFT JOINT. IT WAS STATED THE PATIENT USED ICE PACKS ON IT EVERY NIGHT AND MORNING AND ONLY ATE SOFT FOODS BECAUSE SHE HAD DIFFICULTY EATING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Difficulty Chewing; Pain

  MAUDE report 8116782 ↗
• InjuryNov 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS PRESCRIBED FLEXERIL FOR THIRTY DAYS FOR HER PAIN IN HER LEFT JOINT. IT WAS STATED THE PATIENT USED ICE PACKS ON IT EVERY NIGHT AND MORNING AND ONLY ATE SOFT FOODS BECAUSE SHE HAD DIFFICULTY EATING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Difficulty Chewing; Pain

  MAUDE report 8116770 ↗

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-0519-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 55mm Lft 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-0516-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off 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-0514-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off 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-0517-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Rt 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-0509-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
• Z-0513-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Lft Narrow 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-0512-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off 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.