TMJ SYSTEM 24-6555TIRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841036081348), received between Mar 2, 2021 and Jul 21, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2022Device Dislodged or Dislocated

  IT WAS REPORTED THAT FOLLOWING A STOCK TEMPOROMANDIBULAR JOINT REPLACEMENT CASE, THE PATIENT DISLOCATED THE JOINT IN THE EARLY POST- OP PHASE. FOLLOWING A CT SCAN IT WAS DETERMINED THAT DURING IMPLANTATION THE MANDIBLE COMPONENT ROTATED SLIGHTLY FROM ITS IDEAL POSITION CAUSING THE DISLOCATION. THE MANDIBLE COMPONENT WAS REPOSITIONED IN A SEPARATE PROCEDURE LATER THAT DAY SO THAT IT SAT IN THE FOSSA BETTER AND DOES NOT DISLOCATE. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 15073846 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WILL UNDERGO A REVISION IN A FEW WEEKS DUE TO INCREASING PAIN AND LIMITED RANGE OF MOTION FIVE (5) YEARS FOLLOWING IMPLANTATION OF TEMPOROMANDIBULAR JOINT IMPLANTS ON THE RIGHT SIDE. THE PATIENT INDICATES THAT THEY HAVE SARCOIDOSIS WITH UNKNOWN ETIOLOGY AND THEY ARE UNABLE TO TAKE A METAL ALLERGY TEST DUE TO TAKING HIGH DOSES OF STEROIDS THAT MAY PRODUCE A FALSE NEGATIVE. A CT SCAN INDICATED HETEROTOPIC OSSIFICATION AROUND THE IMPLANT. THE PATIENT HAS ALMOST NO JAW MOVEMENT. A BILATERAL REVISION AND REPLACEMENT WITH CUSTOM DEVICES IS PLANNED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 11398523 ↗

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-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-0511-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Rt 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-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-0521-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Lft Standard 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-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-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-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.