MAUDE Adverse Event Report: Biomet Microfixation 50MM RT STANDARD MAND; Joint, Temporomandibular, Implant

Catalog Number	24-6550
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Discomfort (2330); Partial Hearing Loss (4472)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 2 years post-implantation the patient alleges the right implant was extending into the ear and causing hearing loss.Further, the patient described a sensation like cotton in the right ear with some discomfort but no pain.The patient is speaking with the surgeon, but no further intervention has been reported to date.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: 50MM RT STANDARD MAND
• 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: 50036260
• Report Number: 0001032347-2026-00221
• Device Sequence Number: 10408930
• Product Code: LZD
• UDI-Device Identifier: 00841036060343
• UDI-Public: (01)00841036060343(17)280327(10)159280B
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 24-6550
• Device Lot Number: 159280B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2023
• 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; Disability
• Patient Sex: Female