TMJ SYSTEM 01-6545Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00841036011857), received between Nov 30, 2016 and Mar 4, 2025 — classified as 15 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2025Adverse 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: Insufficient Information

  MAUDE report 21515434 ↗
• InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TMJ REPLACEMENT SURGERY APPROXIMATELY ONE YEAR AGO. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING PAIN AND SWELLING. THE PATIENT HAS RECEIVED BOTOX SHOTS, GABAPENTIN, ANTIBIOTICS, PHYSICAL THERAPY, AND ALLERGY TESTING WHICH WAS NON-REACTIVE. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 18534055 ↗
• InjuryJan 17, 2024Adverse 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 THAT A PATIENT UNDERWENT A TMJ ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAS A FOLLOW UP WITH THE ORAL SURGEON BECAUSE OF AN UNKNOWN ISSUE WITH THE IMPLANT. NO FURTHER INTERVENTION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Pain

  MAUDE report 18526047 ↗
• InjuryOct 5, 2023Adverse 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: Pain

  MAUDE report 17877677 ↗
• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAS EXPERIENCED MULTIPLE ISSUES FOLLOWING IMPLANTATION OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS THREE (3) YEARS AGO. IMMEDIATELY FOLLOWING IMPLANTATION, THE PATIENT DEVELOPED BELL¿S PALSY ON THE RIGHT SIDE AND WAS INFORMED BY THE SURGEON THAT IT WAS A POSSIBLE REACTION TO THE SURGERY. THE PATIENT HAS USED A BITE SPLINT FOR THREE (3) YEARS TO ALIGN THE BITE. THE PATIENT HAD A ROOT CANAL A COUPLE MONTHS AGO AND THE ENDODONTIST TOOK CONE BEAM IMAGING. BASED ON THE IMAGING, THE ENDODONTIST BELIEVES THE DEVICE IS RUBBING THE BONE AND THAT THE SPLINT INCREASES THE PAIN. THE PATIENT HAS AN UNSPECIFIED ONE (1) INCH DEFORMITY IN THE JAW. THE PATIENT UNDERWENT A DRY NEEDLING TREATMENT ONE (1) YEAR AGO THAT DID NOT PROVIDE ADEQUATE PAIN RELIEF. THE PATIENT WISHES TO GET A REFERRAL TO A NEUROLOGIST TO SEE IF A SCREW IS POTENTIALLY HITTING A NERVE. THE PATIENT IS CURRENTLY RECEIVING BOTOX SHOTS IN THE JAW FROM THEIR DENTIST IN ORDER TO TRY TO RELAX THE MUSCLES. THE PATIENT IS NOT INTERESTED IN A REVISION SURGERY UNLESS IT WOULD BRING PAIN RELIEF. THE PATIENT HAS BEEN TOLD BY AN ORAL SURGEON THAT THE PATIENT HAS EXPERIENCED TOO MUCH BONE LOSS TO UNDERGO ADDITIONA

  Patient problems: Facial Nerve Paralysis; Inadequate Pain Relief; Nerve Damage; Pain

  MAUDE report 10689168 ↗
• InjurySep 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 10590298 ↗
• InjurySep 22, 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: Insufficient Information; No Information

  MAUDE report 10566319 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF TEMPOROMANDIBULAR IMPLANTS ON THE RIGHT SIDE DUE TO HETEROTOPIC BONE GROWTH. LEADING UP TO THE REVISION, THE PATIENT COMPLAINED OF INCREASED PAIN. DURING THE REVISION, EXCESS BONE GROWTH WAS REMOVED AROUND THE JOINT AND THE FOSSA COMPONENT WAS REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Extraskeletal ossification; Pain

  MAUDE report 9706098 ↗
• InjuryNov 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; Loss of Range of Motion; No Clinical Signs, Symptoms or Conditions; No Code Available; Pain; Scar Tissue

  MAUDE report 9365760 ↗
• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED NERVE DAMAGE AND NUMBNESS AFTER IMPLANTATION OF TEMPOROMANDIBULAR JOINT IMPLANTS. THE PATIENT DESCRIBED NUMBNESS ON THE RIGHT BOTTOM OF THEIR JAW AND LOSS OF FACIAL EXPRESSION. THE PATIENT SAID THEY ARE ONLY RECENTLY ABLE TO CLOSE THEIR EYES. THE PATIENT CURRENTLY RECEIVES BOTOX INJECTIONS INTO THEIR FOREHEAD TO HELP TREAT THE ISSUES ASSOCIATED WITH THE NERVE DAMAGE. THE PATIENT REPORTED THEIR SURGEON STATED THAT THE CONDITION IS LIKELY PERMANENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Nerve Damage; Numbness

  MAUDE report 8867870 ↗
• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO REPOSITION TEMPOROMANDIBULAR IMPLANTS DUE TO NECROSIS AND BEING TOO CLOSE TO THE EAR CANAL. IMPLANTS REMAIN IMPLANTED. THE PATIENT EXPERIENCED NUMBNESS ON THE RIGHT BOTTOM OF THEIR JAW AND LOSS OF FACIAL EXPRESSION THAT HAS NOT RESOLVED FOLLOWING THE REPOSITIONING OF THE IMPLANTS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Necrosis; Nerve Damage; Numbness

  MAUDE report 8867840 ↗
• InjuryJun 12, 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: Hematoma; Unspecified Infection

  MAUDE report 8692623 ↗
• InjuryMay 24, 2019Noise, Audible; Noise, Audible

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

  Patient problems: Difficulty Chewing; Dysphagia/ Odynophagia; Dysphasia; Headache; Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 8642623 ↗
• InjuryApr 4, 2019Material Erosion; Particulates; Material Erosion; Particulates

  IT WAS REPORTED THAT A REVISION IS PLANNED FOR THE PATIENT DUE TO AN ALLERGIC REACTION AND THE PRESENCE OF POLYETHYLENE PARTICLES. THE PATIENT HAS DEVELOPED PERIODIC FACIAL SWELLING THROUGHOUT THE LAST YEAR. A BIOPSY OF THE SITE SHOWED POLYETHYLENE PARTICLES; NO INFECTION WAS FOUND. THE PATIENT WILL HAVE A REVISION DUE TO WEAR OF THE FOSSA. ALLERGY TESTING CAME BACK AS REACTIVE; AN ALL TITANIUM IMPLANT IS NEEDED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Swelling

  MAUDE report 8482519 ↗
• InjuryNov 30, 2016Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT REPORTED HER JAW FREEZES UP NOW AND THEN AND THERE MAY BE A REVISION SURGERY DUE TO THE ISSUES SHE IS EXPERIENCING. MULTIPLE ATTEMPTS WERE MADE, HOWEVER NO ADDITIONAL INFORMATION WAS RECEIVED AND THE REVISION WAS NOT CONFIRMED.

  Patient problems: Difficulty Chewing; Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 6136535 ↗

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-0519-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 55mm Lft 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-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-0517-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Rt Standard 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-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-0512-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm 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-0513-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Lft 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-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.