TMJ SYSTEM 01-6546Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00841036011871), received between Nov 30, 2016 and Feb 10, 2025 — classified as 19 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT A PATIENT UNDERWENT A REVISION OF LEFT TMJ ARTHROPLASTY PRODUCTS DUE TO A RECALL OF COMPETITOR PRODUCTS APPROXIMATELY SIX (6) YEARS AND NINE (9) MONTHS AGO. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED DROOLING ASSOCIATED WITH NUMBNESS AND A DROOPING EYELID. A FEW YEARS LATER, THE PATIENT DEVELOPED INCREASED PAIN, SWELLING, DEVIATION IN MOUTH OPENING, AND FATIGUE WITH CHEWING PRIOR TO A TEETH EXTRACTION SURGERY. AFTER THE EXTRACTION, THE LEFT SYMPTOMS RESOLVED, BUT THE PATIENT BEGAN EXPERIENCING COMPLICATIONS WITH THE CONTRALATERAL JAW, WHICH DOES NOT CONTAIN IMPLANTS, INCLUDING JAW DISCOMFORT, NECK INVOLVEMENT, EARACHES, AND HEADACHES. RADIOGRAPHIC IMAGING SHOWS ALL IMPLANTS REMAIN IN PLACE WITH NO EVIDENCE OF COMPLICATIONS. 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 21344531 ↗
• 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 18526054 ↗
• 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 18519187 ↗
• 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 17877709 ↗
• InjuryJan 10, 2022Migration; Migration

  IT WAS REPORTED BY THE PATIENT THAT THE PROSTHESIS WAS REMOVED AND REPLACED WITH A CUSTOM IMPLANT BECAUSE IT WAS GOING INTO THE BRAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 13213669 ↗
• 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 10689161 ↗
• 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 10590368 ↗
• 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 10566333 ↗
• InjuryAug 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY ARE EXPERIENCING VARIOUS ISSUES FOLLOWING IMPLANTATION OF TEMPOROMANDIBULAR JOINT IMPLANTS ON THE LEFT SIDE APPROXIMATELY ELEVEN (11) YEARS AGO. THE IMPLANTING SURGEON REPORTS THAT THERE WERE NO ISSUES WITH THE IMPLANTS DURING FOLLOW-UP APPOINTMENTS. THE PATIENT REPORTS A GASH ON THE INSIDE OF THE RIGHT CHEEK. THE PATIENT HAS RECEIVED NERVE BLOCKS THAT ARE INADEQUATE IN PROVIDING PAIN RELIEF. THE PATIENT REPORTS SEEING A NEUROSURGEON FOR A NEUROSTIMULATOR IMPLANT TO TREAT PAIN. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Headache; Inadequate Pain Relief; Pain

  MAUDE report 10367774 ↗
• InjuryMay 20, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT ATTENDED ORAL THERAPY SESSIONS AND A POTENTIALLY LOOSE SCREW WAS DISCOVERED FOLLOWING IMPLANTATION OF TEMPOROMANDIBULAR IMPLANTS ON THE LEFT SIDE ELEVEN (11) MONTHS AGO. THE PATIENT REPORTS SWELLING ON THE LEFT SIDE OF THE MOUTH AND FACE, AND REPORTS DIFFICULTY SLEEPING ON THE LEFT SIDE. THE PATIENT ATTENDED TEN ORAL THERAPY SESSIONS TO REPORTEDLY BREAK DOWN SCAR TISSUE, AND THE THERAPIST DISCOVERED A POSSIBLY LOOSE SCREW. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Sleep Dysfunction; Swelling

  MAUDE report 10075826 ↗
• InjuryDec 23, 2019Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Edema; Erythema; No Code Available; Pain; Unspecified Infection

  MAUDE report 9511431 ↗
• 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 8867874 ↗
• 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 8867844 ↗
• InjuryJul 4, 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. THE PATIENT REPORTS SHE IS ON MANY ORAL PAIN MEDICATIONS AND ANTI-INFLAMMATORIES, AND HAS TRIED MEDICAL MARIJUANA FOR PAIN RELIEF. THE PATIENT REPORTS THAT SHE HAS BEEN ADVISED BY AN ORAL SURGEON NOT TO HAVE ANY MORE WORK PERFORMED ON HER JAW.

  Patient problems: Abdominal Pain

  MAUDE report 8762949 ↗
• 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 8692630 ↗
• 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 8642617 ↗
• InjuryApr 18, 2019Naturally Worn

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

  Patient problems: Reaction; Swelling

  MAUDE report 8528277 ↗
• 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 8482535 ↗
• 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 6136534 ↗

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-0520-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 55mm 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-0512-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Rt 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-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-0516-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm 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-0513-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Lft 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-0521-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Lft 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-0511-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm 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-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.