MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT; 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 Information (3190)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event has been recorded by zimmer biomet under complaint (b)(4).The complaint investigation is in process.Once the investigation has been completed, and product return has been evaluated , if available, a follow up mdr will be submitted.Udi (b)(4).Medical products.Tmj system left fossa component, small-part #24-6563, lot#606810b, udi (b)(4).Tmj system right fossa component, small part# 24-6562, lot#614980b, udi (b)(4).Tmj system right standard mandibular component, part #24-6550, lot# 575530b, udi (b)(4).Unknown screws, part# unknown, lot# unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00182; 0001032347-2020-00178; 0001032347-2020-00180.
Event or Problem Description
It was reported the patient underwent a revision and replacement of bilateral temporomandibular joint implants five years following implantation due to an unknown reason.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is considered to be confirmed as a revision surgery was reported.No product was returned; therefore, no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.The failure mode which led to the need for a revision surgery could not be determined from the information provided.The dhr for the mandible component was reviewed.No non-conformances were found for this component.This is the only complaint for this item# 24-6551, lot# 606810b.The most likely underlying cause of the complaint cannot be determined.There are no indications of manufacturing defects.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
This follow-up report is being submitted to relay additional information.

• Brand Name: TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9897129
• Report Number: 0001032347-2020-00181
• Device Sequence Number: 2764458
• Product Code: LZD
• UDI-Device Identifier: 00841036060329
• UDI-Public: 00841036060329
• 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: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2020

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: 10/01/2015
• Device Model Number: N/A
• Device Catalogue Number: 24-6551
• Device Lot Number: 452880A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 09/08/2020
• 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
• Patient Age: 49 YR