TMJ SYSTEM 24-6546Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00841036036454), received between Jun 7, 2019 and Aug 12, 2024 — classified as 18 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A TMJ PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS HAVING AN UNSPECIFIED TROUBLE WITH THE LEFT JAW. AN MRI WAS PERFORMED THAT SHOWED SOME CHANGES IN THE JOINT PART ITSELF AND POSSIBLY NEED REPLACING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 19961487 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Loss of Range of Motion

  MAUDE report 19510614 ↗
• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 7 YEARS AND 8 MONTHS POST IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19111525 ↗
• InjuryNov 7, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18084285 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS ALLEGING EXPERIENCING PAIN AT A LEVEL SIX. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 18040363 ↗
• InjuryAug 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

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

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 17499833 ↗
• InjuryNov 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION BECAUSE THE IMPLANT FRACTURED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 15707810 ↗
• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BILATERAL TMJ REPLACEMENT SURGERY APPROXIMATELY FOUR YEARS AGO AND IS NOW EXPERIENCING PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 14645808 ↗
• InjuryAug 18, 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: Hearing Impairment

  MAUDE report 12337972 ↗
• InjuryMay 11, 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: Extraskeletal ossification; Loss of Range of Motion; Pain; Rheumatoid Arthritis

  MAUDE report 11808164 ↗
• InjuryFeb 1, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION OF TEMPOROMANDIBULAR JOINT IMPLANTS ON THE LEFT SIDE TWO (2) YEARS FOLLOWING IMPLANTATION DUE TO UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; No Information

  MAUDE report 11259940 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE HAD AN OPERATION TO CLEAN OUT HER JOINT APPROXIMATELY NINE (9) YEARS FOLLOWING IMPLANTATION OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

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

  MAUDE report 10364357 ↗
• InjuryApr 10, 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: Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 9949687 ↗
• InjuryMar 10, 2020Migration or Expulsion of Device; Material Integrity Problem; Migration or Expulsion of Device; Material Integrity Problem

  IT WAS REPORTED THE PATIENT HAS EXPERIENCED MULTIPLE ISSUES WITH HER BILATERAL TEMPOROMANDIBULAR JOINT PROSTHESES SINCE IMPLANTATION THIRTEEN YEARS AGO. THE PATIENT REPORTED SYMPTOMS AND PROCEDURES INCLUDING NERVE DAMAGE, NEUROMA REMOVAL, X-RAYS, BOTOX INJECTIONS, CT SCAN, PAIN, DIFFICULTY CHEWING, DIFFICULTY EATING AND A PLANNED REVISION. THE PATIENT REPORTED THE NERVE DAMAGE OCCURRED IMMEDIATELY AFTER IMPLANTATION WHICH RESULTED IN HER BEING UNABLE TO BLINK HER RIGHT EYE OR MOVE HER RIGHT EYEBROW. THE PATIENT REPORTED A NEUROMA WAS REMOVED FROM THE RIGHT SIDE OF HER JAW SEVEN YEARS AGO. THE PATIENT REPORTED SHE HAD X-RAYS TAKEN BY A DENTIST AND WAS INFORMED THAT A SCREW ON THE RIGHT SIDE IS NOT INTACT. THE PATIENT REPORTED RECEIVING BOTOX TO HER FACE APPROXIMATELY ONE YEAR AGO TO TREAT PAIN, BUT STATED THAT IT DID NOT PROVIDE RELIEF AND AGGRAVATED THE PAIN FURTHER. THE PATIENT REPORTED A CT SCAN WAS TAKEN FOUR MONTHS AGO AND REVEALED THAT TWO SCREWS ON THE RIGHT SIDE WERE NOT INTACT AND WERE NOT STABLE. THE PATIENT REPORTED SHE HAS EXCRUCIATING PAIN, DIFFICULTY CHEWING, AND DIFFICULTY EATING. SHE STATED DUE TO THE DIFFICULTY EATING, SHE CHOKES ON HER FOOD. ADDITIONALLY, SHE REPOR

  Patient problems: Difficulty Chewing; Facial Nerve Paralysis; Feeding Problem; Inadequate Pain Relief; Nerve Damage; Pain

  MAUDE report 9811054 ↗
• InjuryFeb 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION SURGERY DUE TO HETEROTOPIC BONE GROWTH AND DISLOCATION INVOLVING BILATERAL TEMPOROMANDIBULAR JOINT PROSTHESES. THE PATIENT WAS RECEIVED STOCK IMPLANTS OVER A DECADE AGO, AND CURRENTLY REPORTS LIMITED RANGE OF MOTION, HEADACHES, PAIN AND SWELLING. FIFTEEN MONTHS AGO, THE PATIENT REPORTED HETEROTOPIC OSSIFICATION IN THE JOINT AND IMPLANT DISLOCATION ON THE RIGHT SIDE. THIRTEEN MONTHS AGO, THE PATIENT REPORTED A REVISION SURGERY IN WHICH THE EXISTING IMPLANTS WERE RE-POSITIONED. TRIGGER POINT INJECTIONS AND NERVE BLOCKS HAVE BEEN INADEQUATE REGARDING PAIN MANAGEMENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Extraskeletal ossification; Headache; Inadequate Pain Relief; Limited Mobility Of The Implanted Joint; Pain; Swelling

  MAUDE report 9677217 ↗
• InjuryOct 10, 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: Blurred Vision; Swelling

  MAUDE report 9175284 ↗
• InjuryOct 4, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9158501 ↗
• InjuryJun 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: No Information

  MAUDE report 8679529 ↗

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-0515-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Rt Narrow 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-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-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-0519-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 55mm Lft 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-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-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-0509-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
• Z-0520-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 55mm Rt 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.