MAUDE Adverse Event Report: BIOMET MICROFIXATION 45MM LFT NARROW MAND; TOTAL TEMPPOROMANDIBULAR JOINT PROSTHESIS

Model Number N/A

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported by the patient that the prosthesis was removed and replaced with a custom implant because it was going into the brain.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Concomitant medical products: zimmer biomet tmj system left fossa component, small catalog#: 01-6563 lot#: 671970a.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 report: 0001032347-2022-00028.

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.Medical records were not provided.Review of the device history records 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: 45MM LFT NARROW MAND
• Type of Device: TOTAL TEMPPOROMANDIBULAR JOINT PROSTHESIS
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: merrianne cassidy ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 13213669
• MDR Text Key: 283816139
• Report Number: 0001032347-2022-00027
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036011871
• UDI-Public: (01)00841036011871(17)210420(10)670440
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2021
• Device Model Number: N/A
• Device Catalogue Number: 01-6546
• Device Lot Number: 670440B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention