MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT FOSSA COMPONENT, MEDIUM; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Fatigue (1849); Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	02/18/2021
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 is reported that the patient experience a left side tmj fossa component revision due to an unknown reason.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to update additional information in section a2, b4, b5, g3, g6, h2, and h10.
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.Review of the device history record(s) 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
It is further reported the patient had a temporomandibular arthroplasty revision and later underwent a revision due to heterotopic bone growth, pain, swelling,jaw fatigue, and decreased range of motion.The fossa component was exchanged and the procedure was completed without complications.
Additional Manufacturer Narrative
This report is being submitted to update additional information in section a1, a2, a3, a4, a5, b3, b4, b5, b7, g3, g6, h2, h3, h6 and h10.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following.Two panorex views of the jaw demonstrated bilateral mandible plate devices.Post surgical changes of the left mandibular fossa are seen on the pre-revision images but artifact limits evaluation on the post-revision images.No fracture.Pre-revision images demonstrate bony growth of the left mandibular fossa with significant spacing of the tmj, of uncertain etiology.This could be a cause for revision.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following.In december 2019, the patient was given bilateral botox injection to temporalis/masseter.(b)(6), 2020, the patient complained of pain to temporalis tendon without relief from previous botox, hardware was determined to be in the correct position but left medial condylar heterotopic bone was noted via cbct, botox injection was repeated, and the patient was concerned for prominence of left joint prosthesis.(b)(6), 2021, patient experienced pain and swelling, achy, sore, constant, intermittent throbbing, increased jaw fatigue, increasing pain along left temporomandibular joint and decreased range of motion.(b)(6), 2021, progressively developing more limited rom, chin deviation, left sided pain, and again cbct confirmed hardware was in correct position with heterotopic bone noted.Dense tissue around around the device and heterotopic bone were removed.A definitive root cause cannot be determined.

• Brand Name: TMJ SYSTEM LEFT FOSSA COMPONENT, MEDIUM
• 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: 15085596
• Report Number: 0001032347-2022-00225
• Device Sequence Number: 3879334
• Product Code: LZD
• UDI-Device Identifier: 00841036036546
• UDI-Public: (01)00841036036546(17)200911(10)634200
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/27/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2020
• Device Model Number: N/A
• Device Catalogue Number: 24-6561
• Device Lot Number: 634200B
• 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: 06/29/2022
• Supplement Date Received by Manufacturer: 08/09/2022; 09/26/2022; 10/06/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 08/17/2022; 09/30/2022; 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: White