TMJ SYSTEM 24-6545Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00841036036430), received between Jun 7, 2019 and Aug 17, 2026 — classified as 23 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 17, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  It was reported that the patient underwent bilateral temporomandibular joint replacements. Subsequently, the patient underwent a right revision procedure approximately seven (7) years post-implantation. The mandible and fossa were removed and replaced due to unknown reasons. Attempts have been made and no further information has been provided.

  Patient problems: Insufficient Information; Swelling/ Edema

  MAUDE report 50279198 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  It was reported the patient underwent a right temporomandibular procedure. Subsequently, the patient is alleging to be experiencing pain and swelling in the face and near the eye. Further, the patient has alleged that there is an abscess on the outside of the gum that is causing a bad odor in the mouth. There has been no further intervention to date.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 22937107 ↗
• InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Noise, Audible

  THE PATIENT FURTHER REPORTED A HISTORY OF SEVERAL HEAD TRAUMAS WITH MULTIPLE CONCUSSIONS AFTER THE PRODUCT WAS IMPLANTED.

  Patient problems: Pain

  MAUDE report 18585368 ↗
• InjuryJan 11, 2024Adverse 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491920 ↗
• 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 17499842 ↗
• InjuryApr 5, 2023Noise, Audible; Noise, Audible

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

  Patient problems: Pain

  MAUDE report 16681066 ↗
• InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SIDE REVISION FOR UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 15411796 ↗
• MalfunctionNov 8, 2021Malposition of Device; Malposition of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770318 ↗
• InjuryNov 2, 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: Erythema

  MAUDE report 12737903 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A TMJ DUE TO HETEROTOPIC BONE FORMING AROUND PREVIOUS PROSTHESIS CAUSING PAIN AND LIMITED OPENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 12467415 ↗
• 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 12338004 ↗
• InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A REVISION OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS SEVEN (7) YEARS FOLLOWING IMPLANTATION DUE TO UNKNOWN REVISION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11990695 ↗
• 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 11808297 ↗
• 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 10364349 ↗
• 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 9949677 ↗
• InjuryMar 10, 2020Migration or Expulsion of Device; Material Integrity Problem; Migration or Expulsion of Device; Material Integrity Problem

  IT WAS INITIALLY REPORTED THAT THE PATIENT WOULD UNDERGO A REVISION TO REMOVE TEMPOROMANDIBULAR JOINT IMPLANTS ON THE RIGHT SIDE. ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED WHILE THE FOSSA COMPONENT WOULD BE REMOVED, THE MANDIBLE COMPONENT WOULD NOT BE REVISED. THERE IS NO INDICATION OF A DEVICE PROBLEM WITH THE MANDIBLE COMPONENT, AND IT WILL NOT BE REMOVED IN A REVISION. THEREFORE, THE MANDIBLE COMPONENT NO LONGER MEETS THE CRITERIA OF A REPORTABLE EVENT.

  Patient problems: Difficulty Chewing; Feeding Problem; Inadequate Pain Relief; Pain

  MAUDE report 9813414 ↗
• 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 9811051 ↗
• 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 9677207 ↗
• InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT CANNOT OPEN THEIR MOUTH AS WIDE AS THEY WOULD LIKE. THE DOCTOR HAS ADMINISTERED BOTOX AND THE PATIENT DOES NOT REPORT ANY RELIEF. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Loss of Range of Motion

  MAUDE report 9574437 ↗
• 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 9564895 ↗
• InjuryDec 26, 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: No Information

  MAUDE report 9520257 ↗
• InjuryOct 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED FACIAL SWELLING AND BLURRY VISION FOLLOWING THE IMPLANTATION OF TEMPOROMANDIBULAR JOINTS. THE PATIENT WAS PRESCRIBED CELEBREX AND MELOXICAM TO TREAT THE FACIAL SWELLING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Blurred Vision; Swelling

  MAUDE report 9175305 ↗
• InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION TO REMOVE THE TEMPOROMANDIBULAR JOINTS ON THE RIGHT SIDE. THE SURGEON REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO HETEROTOPIC BONE GROWTH. A NEW TEMPOROMANDIBULAR JOINT WAS IMPLANTED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Extraskeletal ossification; Pain

  MAUDE report 9120746 ↗
• 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 8679478 ↗

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-0511-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Rt Narrow 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-0509-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
• 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-0517-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm 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-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-0518-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi 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-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.