TMJ SYSTEM 24-6551Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00841036060329), received between Nov 29, 2018 and Aug 12, 2024 — classified as 24 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2024Malposition of Device; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  IT WAS REPORTED THE PATIENT UNDERWENT A BILATERAL TMJ PROCEDURE. SUBSEQUENTLY, THE PATIENT IS NOW EXPERIENCING PAIN, DIFFICULTY CHEWING, AND HAS DIFFICULTY OPENING THE MOUTH. THE PATIENT ALSO NOW HAS AN OVERBITE, IMPAIRED SPEECH, NUMBNESS ON BOTH SIDES OF HER HEAD, THE LOWER LIP, AND RIGHT SIDE OF THE FACE. WHEN THE PATIENT CAN CHEW, THERE IS A SQUEAKING NOISE COMING FROM THE IMPLANTS. THE PATIENT¿S JAW CLENCHING HAS ALSO WORSENED SINCE THE PROCEDURE. THERE HAS BEEN NO REPORTED INTERVENTION TO DATE.

  Patient problems: Bruxism; Difficulty Chewing; Loss of Range of Motion; Numbness; Pain; Speech Disorder

  MAUDE report 19961380 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN, SWELLING, AND DIFFICULTY OPENING THEIR MOUTHS (ROM) POST IMPLANTATION OF A TMJ PROSTHESIS. A SCREW FRACTURED AND ONLY PART OF IT WAS REMOVED. THE REST WAS RETAINED BY THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 17559949 ↗
• InjuryApr 18, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT IS REPORTED THAT THE PATIENT¿S REVISION PROCEDURE WAS PLANNED DUE TO DISLOCATION AND INFECTION. HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 16764165 ↗
• InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BEGAN EXPERIENCING PAIN, SWELLING, CLICKING, AND POPPING OF HER LEFT TEMPOROMANDIBULAR JOINT APPROXIMATELY SIX MONTHS POSTOPERATIVE. THE PATIENT IS IN PHYSICAL THERAPY, BUT STATED THAT THE PAIN IS GETTING WORSE. NO REVISION PROCEDURES HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 16315180 ↗
• InjuryJan 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 16252855 ↗
• InjuryJun 28, 2022Appropriate Device Problem Term/Code Not Available

  IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO AN UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 14842746 ↗
• InjuryJan 8, 2021Adverse 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: Discomfort; Limited Mobility Of The Implanted Joint; Pain; Swelling; Unspecified Infection

  MAUDE report 11140150 ↗
• 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: Purulent Discharge; Unspecified Infection

  MAUDE report 10856513 ↗
• InjuryOct 16, 2020Adverse 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

  MAUDE report 10691201 ↗
• InjuryAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THAT PATIENT THAT THEY EXPERIENCED AN INFECTION THAT WAS TREATED WITH BACTRIM. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 10472452 ↗
• InjuryAug 31, 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: Arthritis; Pain; Unspecified Infection

  MAUDE report 10471986 ↗
• 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

  IT WAS REPORTED THE PATIENT WILL UNDERGO A REVISION OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS TWENTY (20) YEARS AFTER IMPLANTATION. THE PATIENT REPORTS PAIN AND THE APPEARANCE OF BONY GROWTH. A REVISION IS PLANNED BUT HAS NOT BEEN SCHEDULED. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Extraskeletal ossification; Pain

  MAUDE report 10152646 ↗
• 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 10112038 ↗
• InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION AND REPLACEMENT OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS FIVE YEARS FOLLOWING IMPLANTATION DUE TO AN UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Information

  MAUDE report 9897129 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION ON THE LEFT SIDE EIGHT (8) MONTHS FOLLOWING IMPLANTATION OF BILATERAL TEMPOROMANDIBULAR JOINT PROSTHESES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Information

  MAUDE report 9848806 ↗
• InjuryMar 2, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IT WAS REPORTED THE PATIENT WILL UNDERGO REMOVAL OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS DUE TO PAIN, MALOCCLUSION, AND MALPOSITIONING WITH EROSION OF THE EXTERIOR AUDITORY CANAL. THE SURGEON DOES NOT BELIEVE THE DEVICES ARE DEFECTIVE.

  Patient problems: Neurological Deficit/Dysfunction; Pain

  MAUDE report 9776477 ↗
• InjuryJan 8, 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 IMPLANTS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Information

  MAUDE report 9564912 ↗
• InjuryJan 2, 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 LEFT SIDE DUE TO AN UNKNOWN REASON. THE REMOVED IMPLANTS WERE REPLACED WITH STOCK IMPLANTS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9539969 ↗
• InjuryOct 25, 2019Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION TO REMOVE TEMPOROMANDIBULAR IMPLANTS DUE TO AN UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE TO GATHER MORE INFORMATION BUT NONE HAS BEEN PROVIDED. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Code Available; Pain

  MAUDE report 9241959 ↗
• InjuryOct 10, 2019Fracture; Fracture

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

  Patient problems: No Code Available

  MAUDE report 9177373 ↗
• 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 9177288 ↗
• InjuryAug 15, 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: Fibrosis; Foreign Body Reaction; Granuloma; Pain; Reaction

  MAUDE report 8897006 ↗
• InjuryMar 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: Extraskeletal ossification

  MAUDE report 8444979 ↗
• 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 8116748 ↗

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-0516-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off 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-0520-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 55mm Rt Standard 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-0518-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi 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-0510-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off 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-0514-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off 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-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-0512-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm 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-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.