MAUDE Adverse Event Report: Biomet Microfixation 45MM RT STANDARD MANDIBULAR; Joint, Temporomandibular, Implant

Catalog Number	24-6545
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	06/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent bilateral temporomandibular joint replacements.Subsequently, the patient underwent a right revision procedure approximately seven (7) years post-implantation.The mandible and fossa were removed and replaced due to unknown reasons.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).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.

• Brand Name: 45MM RT STANDARD MANDIBULAR
• Common Device Name: 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 ; +1(574)526-0384
• MDR Report Key: 50279198
• Report Number: 0001032347-2026-00254
• Device Sequence Number: 21270408
• Product Code: LZD
• UDI-Device Identifier: 00841036036430
• UDI-Public: (01)00841036036430(17)240813(10)907240
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/01/2024
• Device Catalogue Number: 24-6545
• Device Lot Number: 907240A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 08/17/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female