MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM MANDIBULAR COMPONENT LEFT STANDARD OFFSET TITANIUM; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Health Effect - Clinical Codes	Joint Laxity (4526); Insufficient Information (4580)
Date of Event	09/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (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.
Event or Problem Description
It was reported that a revision was performed due to an unknown reason.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h10 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records for item# 24-6551ti identified no deviations or anomalies during manufacturing.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 or Problem Description
It was reported that the reason for failure was non-integration of hardware screws causing mobility of the left prosthesis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10 - medical product - unknown mandibular screw, catalog#: ni, lot#: ni.

• Brand Name: TMJ SYSTEM MANDIBULAR COMPONENT LEFT STANDARD OFFSET TITANIUM
• 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 ; 5745260384
• MDR Report Key: 14887846
• Report Number: 0001032347-2022-00211
• Device Sequence Number: 5062667
• Product Code: LZD
• UDI-Device Identifier: 00841036081737
• UDI-Public: (01)00841036081737(17)200820(10)613190
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2022

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: Health Professional
• Device Expiration Date: 08/20/2020
• Device Model Number: N/A
• Device Catalogue Number: 24-6551TI
• Device Lot Number: 613190A
• 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: 06/06/2022
• Supplement Date Received by Manufacturer: 06/01/2022; 08/05/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 07/12/2022; 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2015
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female