MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT STANDARD OFFSET MANDIBULAR COMPONENT 50MM / 9 HOLE; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The device will not be returned for analysis as it was retained by the customer for use as a demonstration model; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Concomitant medical products: unknown screws, part# ni, lot# ni.Tmj system left narrow mandibular component 50mm / 7 hole, part# 01-6551, lot# 816470b.
Event or Problem Description
It was reported that the offset mandible component was implanted and then immediately replaced with a narrow mandible component due to the surgeon¿s preference.The surgeon implanted the offset component on the left side and a narrow component on the right side, then decided he made the wrong call with the offset component on the left side.The surgeon was satisfied with the result following the replacement and does not allege any deficiency with the implant.No additional patient consequences have been reported.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Upon further review, it was determined that this is not a reportable event.The surgeon decided intraoperatively to change the implant at his/her discretion, and they stated there was nothing wrong with the implant.

• Brand Name: TMJ SYSTEM LEFT STANDARD OFFSET MANDIBULAR COMPONENT 50MM / 9 HOLE
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10895668
• Report Number: 0001032347-2020-00582
• Device Sequence Number: 3048670
• Product Code: LZD
• UDI-Device Identifier: 00841036064884
• UDI-Public: 00841036064884
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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: Health Professional
• Device Expiration Date: 08/24/2025
• Device Model Number: N/A
• Device Catalogue Number: 24-6651
• Device Lot Number: 998680A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention