MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM RIGHT 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 Codes	Extraskeletal ossification (1428); Loss of Range of Motion (2032)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).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: 0001032347-2020-00523, 0001032347-2020-00524, and 0001032347-2020-00525.Explantation date is planned for (b)(6) 2021 medical products: tmj system left standard mandibular component 50mm / 9 hole, part# 24-6551, lot# 159860.Tmj system left fossa component, small, part# 24-6563, lot# 123880.Tmj system right fossa component, small, part# 24-6562, lot# 228220.Tmj system right standard offset mandibular component 50mm / 9 hole, part# 24-6650, lot# 188200.Unknown screws, part# ni, lot# ni.Initial reporter: patient.
Event or Problem Description
It was reported the patient will undergo a revision of bilateral temporomandibular joint implants thirteen (13) years following implantation due to heterotopic bone growth.The patient feels that the devices have worked well and it is the bony overgrowth that causes a limited range of motion.It is possible the implants will be replaced with a custom device.No additional patient consequences have been reported.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
No product was returned or pictures provided; visual and dimensional evaluations could not be performed.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: TMJ SYSTEM RIGHT 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: 10691222
• Report Number: 0001032347-2020-00526
• Device Sequence Number: 3174604
• Product Code: LZD
• UDI-Device Identifier: 00841036063580
• UDI-Public: 00841036063580
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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: 11/01/2011
• Device Model Number: N/A
• Device Catalogue Number: 24-6650
• Device Lot Number: 188200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 10/05/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention