TMJ SYSTEM 01-6546TIRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841036081782), received between May 20, 2019 and Sep 27, 2024 — classified as 4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 20322860 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING THE RIGHT SIDE OF HER FACE BEING NUMB ALONG WITH STIFFNESS AND LOSS OF MOTION ON BOTH SIDES. THE PATIENT IS FOLLOWING UP WITH A PHYSICIAN.

  Patient problems: Loss of Range of Motion; Numbness

  MAUDE report 13288589 ↗
• InjuryApr 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT WILL UNDERGO A REVISION OF TEMPOROMANDIBULAR JOINT IMPLANTS ON THE LEFT SIDE DUE TO TRAUMA FOLLOWING A FALLING ACCIDENT. A CT SCAN REVEALED THE MANDIBLE BONE FRACTURED AROUND THE IMPLANT AND THE IMPLANT IS DISPLACED. THE DEVICES WILL BE EXPLANTED AND REPLACED WITH A CUSTOM IMPLANT. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 9940058 ↗
• InjuryMay 20, 2019Material Protrusion/Extrusion; Positioning Problem; Material Protrusion/Extrusion; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING SEVERAL NEUROLOGICAL SYMPTOMS SINCE HER TMJ REPLACEMENT SURGERY APPROXIMATELY FOUR MONTHS AGO. THE PATIENT REPORTS THAT ONE OF THE SCREWS WAS PLACED TOO FAR AND IT IS HITTING HER BRAIN WITH SYMPTOMS INCLUDING: SMELLING WEIRD THINGS, HAVING DEJA VU, TROUBLE REMEMBERING WHAT SHE IS GOING TO SAY, HEADACHES, DOUBLE VISION IN THE LEFT EYE AND IRRITABILITY AND SEIZURES. THE PATIENT WAS REFERRED TO A NEUROLOGIST AFTER MENTIONING THE HEADACHES AND REPORTS THE NEUROLOGIST SUGGESTED REMOVING THE SCREW AND REPLACING IT WITH A SMALLER ONE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Blurred Vision; Headache; Irritability; Pain; Seizures

  MAUDE report 8623348 ↗

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-0514-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm 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-0509-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
• Z-0519-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 55mm Lft 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-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-0516-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off 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-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-0515-2015 · Oct 17, 2014 · Terminated
  Total Temporomandibular Joint Replacement System- 50mm Rt Narrow 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-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.