MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SMALL LEFT FOSSA COMPONENT; FOSSA IMPLANT

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Code Available (3191); Increased Sensitivity (4538)

Event Date 04/11/2016

Event Type  Injury  

Manufacturer Narrative

The warnings in the package insert state this type of event can occur.The product was discarded by the hospital and therefore will not be returned for an evaluation.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.This is report one of three of the same event.Reports two and three for the same event is reported on mfr #0001032347-2016-00672 and 0001032347-2016-00673.

Event Description

A temporomandibular joint (tmj) revision surgery was reported to have taken place to replace the left fossa.It is reported the reason for the revision was because the condyle was out of the fossa and the patient was having pain.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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 a1, a2, b4, b5, d4, g3, g4, g6, h2, h6, and h10.

Event Description

It is further reported that the patient experiences noise sensitivity prior to the revision.

Event Description

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

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.Review of the device history records identified no deviations or anomalies during manufacturing of the fossa component.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent an initial left tmj procedure.Subsequently, the patient was revised due to pain and noise sensitivity at which time the left tmj fossa comp was explanted.There was reported sensitivity to loud noises in the left ear that gradually worsened and pain.Patient stated a portion of the implant was leaning against the ear canal causing the issues that were reported.A definitive root cause cannot be determined.The patient stated a portion of the implant was leaning against the ear canal, however, this could not be confirmed.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.

• Brand Name: TMJ SMALL LEFT FOSSA COMPONENT
• Type of Device: FOSSA IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6102500
• MDR Text Key: 59884352
• Report Number: 0001032347-2016-00671
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036036584
• UDI-Public: (01)00841036036584(17)191211(10)578170
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2019
• Device Model Number: N/A
• Device Catalogue Number: 24-6563
• Device Lot Number: 578170B
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2016
• Initial Date FDA Received: 11/15/2016
• Supplement Dates Manufacturer Received: 07/25/2022; 11/21/2022
• Supplement Dates FDA Received: 08/23/2022; 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Sex: Female