TMJ SYSTEM 01-6550Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00841036011895), received between Nov 8, 2019 and Jul 18, 2025 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL BILATERAL TMJ PROCEDURE APPROXIMATELY 3 YEARS AGO. SUBSEQUENTLY, THE PATIENT ALLEGES THE LEFT JOINT BECAME INFECTED SHORTLY AFTER IMPLANTATION CAUSING A HOLE IN THE EAR CANAL. DUE TO THIS, THE PATIENT ALLEGES A STAPH INFECTION OCCURRED. THEREFORE, THE PATIENT UNDERWENT A REVISION WHERE ALL COMPONENTS WERE REMOVED AND REPLACED WITH CUSTOM DEVICES. THE PATIENT ALLEGES THE REVISION SURGEON NOTED WHEN THE ORIGINAL IMPLANTS WERE INITIALLY IMPLANTED, THAT THEY DID NOT FIT PROPERLY AND THE INITIAL SURGEON USED CEMENT TO FORCE THE IMPLANTS TO FIT INTO THE JOINT SPACE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 22541517 ↗
• InjuryJun 14, 2023Adverse 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: Pain

  MAUDE report 17126598 ↗
• InjuryApr 19, 2022Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY ELEVEN (11) YEARS POST-OP DUE TO AN UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 14145758 ↗
• InjuryFeb 1, 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: Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Nerve Damage

  MAUDE report 11263152 ↗
• InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT IS EXPERIENCING PAIN AND DIFFICULTY CHEWING ELEVEN (11) YEARS FOLLOWING IMPLANTATION OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS. THE PATIENT INDICATES THAT THE PAIN IS BETTER THAN BEFORE THE SURGERY BUT IS STILL BEING EXPERIENCED. THE PATIENT REPORTS THAT THEIR JAW HAS SHIFTED SO THAT THEIR TEETH DO NOT TOUCH, AND AS A RESULT THE PATIENT CANNOT CHEW OR TEAR MEAT. THE PATIENT HAS BROKEN SEVERAL TEETH DUE TO BRUXISM AND THEIR DENTIST BELIEVES THE BREAKAGES ARE DUE TO TRAUMA FROM THE INITIAL SURGERY. THE PATIENT RECEIVES BOTOX SHOTS FOR BURNING OR FIRING NERVES THAT CAUSE PAIN. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Difficulty Chewing; Loss of Range of Motion; Pain

  MAUDE report 10791414 ↗
• InjuryOct 28, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Inadequate Pain Relief; Nerve Damage; Pain

  MAUDE report 10747140 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Noise, Audible; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Patient Device Interaction Problem

  IT WAS REPORTED THE PATIENT MAY UNDERGO A REVISION OF TEMPOROMANDIBULAR JOINT IMPLANTS ON THE RIGHT SIDE AT A LATER UNSPECIFIED DATE DUE TO AN UNKNOWN REASON. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Increased Sensitivity; Limited Mobility Of The Implanted Joint; No Information; Pain

  MAUDE report 9546783 ↗
• InjuryNov 8, 2019Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Migration; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Migration

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

  Patient problems: Fibrosis; No Code Available; Pain; Scarring

  MAUDE report 9295759 ↗

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-0522-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Rt Standard 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-0513-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Lft 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-0510-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off 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-0511-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm 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-0514-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Lft 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-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-0515-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Rt 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-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.