MAUDE Adverse Event Report: BIOMET MICROFIXATION RIGHT STANDARD MANDIBULAR COMPONENT; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190); Noise, Audible (3273)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint: (b)(4).D10: medical product - zimmer biomet small right fossa component catalog#: 24-6562, lot#: 398400c; zimmer biomet right standard mandibular component catalog#: 24-6545, lot#: 420070a.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2024-00037.
Event or Problem Description
It was reported that the patient underwent a right side tmj replacement surgery approximately 11 years ago.Subsequently, the patient experiencing pain, squeaking, and that the implant is damaged and in need of replacement.No intervention has been reported to date, but the patient is seeking physician's care.
Event or Problem Description
The patient further reported a history of several head traumas with multiple concussions after the product was implanted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history records 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.

• Brand Name: RIGHT STANDARD MANDIBULAR COMPONENT
• 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: 18585368
• Report Number: 0001032347-2024-00038
• Device Sequence Number: 18193717
• Product Code: LZD
• UDI-Device Identifier: 00841036036430
• UDI-Public: (01)00841036036430(10)420070(17)150401(30)1
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2024

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: 04/01/2015
• Device Model Number: N/A
• Device Catalogue Number: 24-6545
• Device Lot Number: 420070A
• 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: 12/27/2023
• Supplement Date Received by Manufacturer: 02/02/2024; 03/22/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 02/20/2024; 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2012
• 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: Other
• Patient Sex: Unknown