TMJ SYSTEM 99-6577Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00841036057442), received between Mar 6, 2019 and Jan 25, 2023 — classified as 37 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 reports).

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 37 reports, in the reporter's own words as published by the FDA.

• InjuryJan 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Failure of Implant

  MAUDE report 16239807 ↗
• InjuryJan 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Failure of Implant

  MAUDE report 16239803 ↗
• InjuryJan 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Failure of Implant

  MAUDE report 16239799 ↗
• InjuryFeb 4, 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: Discomfort; Limited Mobility Of The Implanted Joint; Pain; Swelling; Unspecified Infection

  MAUDE report 11278212 ↗
• InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT IS EXPERIENCING PAIN AND DIFFICULTY CHEWING ELEVEN (11) YEARS FOLLOWING IMPLANTATION OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS. THE PATIENT INDICATES THAT THE PAIN IS BETTER THAN BEFORE THE SURGERY BUT IS STILL BEING EXPERIENCED. THE PATIENT REPORTS THAT THEIR JAW HAS SHIFTED SO THAT THEIR TEETH DO NOT TOUCH, AND AS A RESULT THE PATIENT CANNOT CHEW OR TEAR MEAT. THE PATIENT HAS BROKEN SEVERAL TEETH DUE TO BRUXISM AND THEIR DENTIST BELIEVES THE BREAKAGES ARE DUE TO TRAUMA FROM THE INITIAL SURGERY. THE PATIENT RECEIVES BOTOX SHOTS FOR BURNING OR FIRING NERVES THAT CAUSE PAIN. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Difficulty Chewing; Loss of Range of Motion; Pain

  MAUDE report 10791429 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

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

  Patient problems: Discomfort; Hearing Loss; Pain; Rupture

  MAUDE report 10777370 ↗
• InjuryOct 28, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Inadequate Pain Relief; Nerve Damage; Pain

  MAUDE report 10747185 ↗
• 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 10689177 ↗
• InjuryOct 6, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Erythema; Itching Sensation; Reaction; Unspecified Infection; Urticaria

  MAUDE report 10637426 ↗
• 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 10590390 ↗
• InjuryAug 31, 2020Adverse 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: Unspecified Infection

  MAUDE report 10472704 ↗
• InjuryAug 31, 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 FACIAL PAIN FOURTEEN (14) MONTHS FOLLOWING IMPLANTATION OF TEMPOROMANDIBULAR JOINT IMPLANTS ON THE LEFT SIDE. THE PATIENT WAS DIAGNOSED WITH A LEFT EAR INFECTION AND TREATED WITH BACTRIM. THE PATIENT HAS ARTHRITIS ON BOTH SIDES OF THE MOUTH AND HAS PREVIOUSLY EXPERIENCED RUBBING OF THE JOINT. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Arthritis; Pain; Unspecified Infection

  MAUDE report 10472043 ↗
• 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 10367745 ↗
• 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 10364401 ↗
• InjuryJul 23, 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: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10318010 ↗
• InjuryJul 13, 2020Migration; Migration

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

  Patient problems: Pain

  MAUDE report 10267503 ↗
• InjuryMay 20, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

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

  Patient problems: Sleep Dysfunction; Swelling

  MAUDE report 10075496 ↗
• 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 9949737 ↗
• InjuryApr 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Bone Fracture(s)

  MAUDE report 9940268 ↗
• InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT IS FURTHER REPORTED THAT THE PATIENT HAS SCAR TISSUE AGAINST LEFT JOINT REPLACEMENT CAUSING MISALIGNMENT AND CREATING A SCISSOR BITE. HER RIGHT SIDE JOINT IS BEING AFFECTED BY COMPENSATION FOR THE LEFT SIDE IMPLANT ISSUES. NO FURTHER INTERVENTION HAS BEEN REPORTED.

  Patient problems: Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 9920593 ↗
• 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 9811089 ↗
• InjuryMar 2, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IT WAS REPORTED THE PATIENT WILL UNDERGO REMOVAL OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS DUE TO PAIN, MALOCCLUSION, AND MALPOSITIONING WITH EROSION OF THE EXTERIOR AUDITORY CANAL. THE SURGEON DOES NOT BELIEVE THE DEVICES ARE DEFECTIVE.

  Patient problems: Neurological Deficit/Dysfunction; Pain

  MAUDE report 9776533 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF TEMPOROMANDIBULAR IMPLANTS ON THE RIGHT SIDE DUE TO HETEROTOPIC BONE GROWTH. LEADING UP TO THE REVISION, THE PATIENT COMPLAINED OF INCREASED PAIN. DURING THE REVISION, EXCESS BONE GROWTH WAS REMOVED AROUND THE JOINT AND THE FOSSA COMPONENT WAS REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Extraskeletal ossification; Pain

  MAUDE report 9706136 ↗
• InjuryJan 15, 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 PROSTHESES DUE TO AN UNKNOWN REASON. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9592312 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION OF TEMPOROMANDIBULAR JOINT IMPLANTS ON THE RIGHT SIDE DUE TO AN UNKNOWN REASON. STOCK MANDIBLE AND FOSSA IMPLANTS WERE REMOVED AND REPLACED WITH NEW STOCK IMPLANTS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9569636 ↗