MAUDE Adverse Event Report: BIOMET MICROFIXATION PM-TMJ & MODEL; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).G3: foreign source: united kingdom.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient underwent a bilateral custom tmj procedure on an unknown date.Subsequently, the patient is being considered for a new custom tmj device due to unknown reasons.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

Upon reassessment of the reported event based on additional information, this product did not cause or contribute to the reported event.This initial report submitted needs to be voided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was further reported that the failure occurred due to heterotrophic bone around the prosthesis and not a primary prosthesis failure.

• Brand Name: PM-TMJ & MODEL
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18821574
• MDR Text Key: 336738623
• Report Number: 0001032347-2024-00068
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036195960
• UDI-Public: (01)00841036195960(17)200601(10)629020
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2020
• Device Model Number: N/A
• Device Catalogue Number: TMJPM-1153
• Device Lot Number: 629020A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2024
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other