inforMED
InjuryMPI

PATIENT MATCHED BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS

Received Oct 26, 2017

Report 0001032347-2017-00771 · MDR key 6979129

Device

Generic name

Custom Joint Implants

Model number

N/A

Catalog number

UNKNOWN

Lot number

UNKNOWN

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • Extraskeletal ossification
  • No Code Available
  • Extraskeletal ossification
  • No Code Available

Narrative

Additional Manufacturer Narrative

THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. THE PRODUCT REMAINS IMPLANTED AND THEREFORE WILL NOT BE RETURNED FOR AN EVALUATION AT THIS TIME. BECAUSE THE PART AND LOT NUMBERS ARE UNKNOWN, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. IT IS STATED THE REVISION IS DUE TO HETEROTOPIC BONE AROUND THE ORIGINAL IMPLANTS AND COMPLEX ANATOMY; THEREFORE THE EVENT IS RELATED TO PATIENT CONDITION. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT A FOLLOW-UP REPORT WILL BE SENT.

Description of Event or Problem

A REVISION SURGERY IS PLANNED FOR (B)(6) 2018 TO REMOVE AND REPLACE BILATERAL TEMPOROMANDIBULAR JOINT (TMJ) IMPLANTS DUE TO HETEROTOPIC BONE AROUND THE EXISTING IMPLANTS. MORE INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED AT THIS TIME.