TMJ SYSTEM 24-6563Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 00841036036584), received between Nov 15, 2016 and Sep 2, 2026 — classified as 88 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 89 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Insufficient Information

  MAUDE report 50566974 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient underwent a TMJ procedure and was subsequently revised approximately 2 years and 8 months post-implantation for an unknown reason. Attempts have been made and no further information has been provided.

  Patient problems: Insufficient Information

  MAUDE report 50565917 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN AFTER UNDERGOING A LEFT TMJ PROCEDURE APPROXIMATELY 8 YEARS AGO. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 23513180 ↗
• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Extraskeletal ossification; Loss of Range of Motion; Pain

  MAUDE report 23335332 ↗
• 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 22541530 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TEMPOROMANDIBULAR JOINT PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS.

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

  MAUDE report 21713008 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT IS REPORTED THAT THE PATIENT UNDERWENT A BILATERAL TEMPOROMANDIBULAR JOINT PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A LEFT SIDE REVISION DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 21445849 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A LEFT TEMPOROMANDIBULAR JOINT IMPLANT PLACED APPROXIMATELY SIX (6) YEARS AND SEVEN (7) MONTHS AGO HAS EXPERIENCED ONGOING DENTAL ISSUES, RANGE OF MOTION LIMITATIONS, AND DISCOMFORT. FOR APPROXIMATELY ONE (1) YEAR AND THREE (3) MONTHS, THE PATIENT HAS BEEN ON A SOFT DIET DUE TO PERSISTENT SYMPTOMS WITHOUT IMPROVEMENT. THE PATIENT UNDERWENT A PROCEDURE TO ADDRESS EXPOSED BONE IN THE GUMS AT AN UNKNOWN TIME. THE PATIENT REPORTS SEVERE PAIN ASSOCIATED WITH DENTURES, NECK DISCOMFORT, EARACHE-LIKE SYMPTOMS, AND HEADACHES. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Difficulty Chewing; Ear Pain; Headache; Loss of Range of Motion; Neck Pain; Numbness; Pain; Ptosis; Swelling/ Edema

  MAUDE report 21344530 ↗
• InjurySep 27, 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; Insufficient Information; Loss of Range of Motion; Numbness; Pain; Paresthesia; Peripheral Nervous Injury; Sensitivity of Teeth; Swelling/ Edema

  MAUDE report 20323075 ↗
• InjuryAug 12, 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 19961481 ↗
• 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 19961390 ↗
• InjuryJul 24, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION IS PLANNED DUE TO BONE LOSS AND THREE FOSSA SCREWS LOOSENING. HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Osteolysis

  MAUDE report 19823429 ↗
• 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

  IT IS REPORTED THAT THE PATIENT UNDERWENT A TMJ REVISION DUE TO BEING UNABLE TO OPEN THE MOUTH, AN UNKNOWN HARDWARE FAILURE, AND SCREWS NOT BEING ATTACHED TO THE BONE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Loss of Range of Motion

  MAUDE report 19510637 ↗
• 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 19106754 ↗
• 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 18526102 ↗
• 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 18519257 ↗
• 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 18084326 ↗
• 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 18040361 ↗
• InjuryOct 11, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

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

  Patient problems: Extraskeletal ossification; Loss of Range of Motion

  MAUDE report 17914084 ↗
• 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 17877696 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN, SWELLING, AND DIFFICULTY OPENING THEIR MOUTHS (ROM) POST IMPLANTATION OF A TMJ PROSTHESIS. A SCREW FRACTURED AND ONLY PART OF IT WAS REMOVED. THE REST WAS RETAINED BY THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 17559799 ↗
• 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 17499846 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TEMPOROMANDIBULAR JOINT PROCEDURE. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING PAIN. CHEWING CAUSES A LOT OF PAIN. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Difficulty Chewing; Pain

  MAUDE report 17360995 ↗
• InjuryMay 30, 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: Numbness; Pain

  MAUDE report 17020590 ↗
• 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 16768339 ↗

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-0521-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm 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-0522-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm 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-0516-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm 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-0509-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
• Z-0518-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi 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-0517-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Rt Standard 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-0514-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Lft 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-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.