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	Purulent Discharge (1812); Unspecified Infection (1930)
Date of Event	07/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).The device will not be returned for analysis as it was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00569.Medical products: tmj system left standard mandibular component 50mm / 9 hole, part# 24-6551, lot# 829370d; tmj system left fossa component, medium, part# 24-6561, lot# 863480c; unknown screws, part# ni, lot# ni.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source ¿ (b)(6).
Event or Problem Description
It was reported the patient underwent a revision to remove temporomandibular joint implants on the left side nine (9) months following implantation due to purulent infection in the ear canal.It is planned that the patient will receive a custom temporomandibular joint implant on the left side in (b)(6) 2021.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
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2; h3; h6 during the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness and the reported infection occurred > 90 days, implanted products are not identified as the source or contributing to the reported infection and can be excluded as a possible source.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• 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
• MDR Report Key: 10856576
• Report Number: 0001032347-2020-00570
• Device Sequence Number: 583359
• Product Code: LZD
• UDI-Device Identifier: 00841036036546
• UDI-Public: 00841036036546
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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: 11/08/2023
• Device Model Number: N/A
• Device Catalogue Number: 24-6561
• Device Lot Number: 863480C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 06/23/2021
• 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: Hospitalization; Required Intervention