MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT 45MM / 7 HOLE; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems No Information (3190); Insufficient Information (4580)

Event Date 12/11/2020

Event Type  Injury  

Manufacturer Narrative

(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: 0001032347-2021-00034.Concomitant medical products: tmj system left fossa component, small, part# 24-6563, lot# 795360c.Unknown mandible screw, part# ni, lot# ni.Unknown fossa screw, part# ni, lot# ni.

Event Description

It was reported the patient underwent a revision of temporomandibular joint implants on the left side two (2) years following implantation due to unknown reason.Attempts have been made and no further information has been provided.

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record for 24-6546 identified no deviations or anomalies during manufacturing related to the reported event.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.This report is being submitted to update additional information in section h2, h3, h6 and h10.

Event Description

No further event information available at the time of this report.

• Brand Name: TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT 45MM / 7 HOLE
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11259940
• MDR Text Key: 229690755
• Report Number: 0001032347-2021-00033
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036036454
• UDI-Public: (01)00841036036454(17)230102(10)789640
• Combination Product (y/n): N
• PMA/PMN Number: P020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2023
• Device Model Number: N/A
• Device Catalogue Number: 24-6546
• Device Lot Number: 789640D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention