TMJ SYSTEM 24-6562Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 00841036036560), received between Nov 30, 2016 and Aug 17, 2026 — classified as 73 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 25 most recent of 76 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 50279195 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL BILATERAL TEMPOROMANDIBULAR JOINT PROCEDURE. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING PAIN AND TIGHTNESS APPROXIMATELY EIGHT YEARS POST-IMPLANTATION. IT IS FURTHER ALLEGED BY THE PATIENT THAT THE SCREWS ARE COMING LOOSE AND PUSHING OUT. THE PATIENT IS TRYING TO FIND A SURGEON TO HAVE THE IMPLANTS REMOVED BUT HAS NOT FOUND ONE THAT WILL DO THE SURGERY. THERE HAS BEEN NO INTERVENTION TO DATE.

  Patient problems: Pain

  MAUDE report 25451137 ↗
• MalfunctionFeb 2, 2026Migration

  IT WAS REPORTED THAT A PATIENT WITH TEMPOROMANDIBULAR JOINT PROSTHESES EXPERIENCED RIGHT-SIDED IMPLANT SHIFTING WITH IMPINGEMENT TOWARD THE EAR CANAL. NO FURTHER INTERVENTION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234267 ↗
• 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 22937084 ↗
• 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 22541515 ↗
• InjuryOct 17, 2024Adverse 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: Fluid Discharge; Loss of Range of Motion; Numbness; Pain; Paresthesia; Peripheral Nervous Injury; Sensitivity of Teeth; Swelling/ Edema

  MAUDE report 20476521 ↗
• InjuryAug 28, 2024Malposition of Device; Malposition of Device

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

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 20087473 ↗
• 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 19961383 ↗
• InjuryJul 30, 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: Insufficient Information

  MAUDE report 19863731 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 18695458 ↗
• 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 18534058 ↗
• 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 18526055 ↗
• InjuryJan 16, 2024Adverse 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 18519179 ↗
• 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 18491929 ↗
• 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 18084313 ↗
• InjuryOct 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SIDE TMJ REPLACEMENT PROCEDURE APPROXIMATELY 2 YEARS AGO. APPROXIMATELY 7 MONTHS LATER, THE PATIENT UNDERWENT A REVISION DUE TO AN UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17949265 ↗
• 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 17877716 ↗
• 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 17499835 ↗
• 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 17126602 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS FURTHER REPORTED THAT THE PATIENT WAS REVISED DUE TO SOFT TISSUE IRRITATION OF THE RIGHT TMJ AREA AFTER INITIAL SURGERY. NO INFECTION WAS FOUND.

  Patient problems: Insufficient Information; Skin Inflammation/ Irritation

  MAUDE report 17024044 ↗
• MalfunctionApr 19, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A TMJ PROCEDURE. SUBSEQUENTLY, THE PATIENT HAS STATED THEY HAVE PAIN AND ARE BARELY ABLE TO OPEN THE JAW. NO INTERVENTION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 16768329 ↗
• InjuryApr 5, 2023Noise, Audible; Noise, Audible

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

  Patient problems: Pain

  MAUDE report 16681041 ↗
• MalfunctionMar 31, 2023Malposition of Device; Noise, Audible; Malposition of Device; Noise, Audible

  IT IS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SIDE TEMPOROMANDIBULAR JOINT REPLACEMENT PROCEDURE. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING DECREASED HEARING ON THE RIGHT SIDE AS WELL AS LOUD SQUEAKING NOISES WHEN EATING. PATIENT ALSO CAN FEEL THE TIP OF THE JOINT WHEN A FINGER IS INSERTED IN THE RIGHT EAR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Facial Paralysis; Hearing Impairment

  MAUDE report 16655544 ↗
• InjuryFeb 1, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT A REVISION IS PLANNED DUE TO PAIN AND WORN PRODUCT. HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 16278239 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A BILATERAL TMJ PROCEDURE, SUBSEQUENTLY. THE PATIENT WAS REVISED ON THE RIGHT SIDE DUE TO UNKNOWN REASONS.

  Patient problems: Abscess; Bacterial Infection; Loss of Range of Motion; No Clinical Signs, Symptoms or Conditions; Pain; Swelling/ Edema

  MAUDE report 16135183 ↗

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-0517-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm 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-0510-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off 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-0521-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Lft 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-0512-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Rt 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-0511-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Rt Narrow 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-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-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.