MAUDE Adverse Event Report: BIOMET MICROFIXATION MARAHAR PM-TMJ & MODEL; CUSTOM MADE DEVICE

Model Number N/A

Device Problems Device Slipped (1584); Migration (4003)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint #: (b)(4).Concomitant medical products: unknown screws catalog #: unknown lot #: unknown.Foreign: (b)(6).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.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2022-00168.

Event Description

It was reported that patient had original surgery to implant custom tmj prostheses approximately two years ago.Subsequently, all of the screws have pulled out and have radiolucencies around them.The surgeon stated that this suggests a systemic bone healing problem.The patient will need a revision, but the surgeon is having her worked up for a bone physiology disorder first as this could be part of her mctd or something different.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; b6; g3; g6; h1; h2; h3; h6; h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.2019 pre-op panorex, 2019 post-op panorex, april 2022 panorex and ct images were provided and reviewed by a health care professional.Review of the available images identified the following: pre-op imaging demonstrated suspected bilateral tmj arthrosis.2019 post-op imaging demonstrates anatomic alignment of bilateral custom tmj arthroplasties without abnormality.April 2022 imaging demonstrates loosening of the bilateral tmj arthroplasties with lucencies along the bilateral screws and slight retraction of the mandibular implants from the osseous margins.There is no osseous or hardware fracture.Patient anatomy appears unremarkable and unchanged, apart from bone quality appears mildly osteopenic.Review of the device history records identified no deviations or anomalies during manufacturing of the patient matched tmj device.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: MARAHAR PM-TMJ & MODEL
• Type of Device: CUSTOM MADE DEVICE
• 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: 14497371
• MDR Text Key: 292695444
• Report Number: 0001032347-2022-00167
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036275044
• UDI-Public: (01)00841036275044(17)241017(10)949090
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TMJPM-2685
• Device Lot Number: 949090A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2019
• 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): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female