MAUDE Adverse Event Report: BIOMET MICROFIXATION CUSTOM MADE DEVICE; CUSTOM TEMPOROMANDIBULAR JOINT REPLACEMENT

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

It was reported by the tmj pmi group that a patient underwent bilateral tmj arthroplasty on an unknown date.Subsequently, the patient will be revised due to malposition of the implants.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).G3: foreign- united kingdom.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted at this time.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

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.The designer of this device was notified of this complaint and an investigation was conducted.The designer reviewed the plan that was sent to the surgeon and confirmed that the guide lined up properly with the screw holes of the implant.It was reported that there was no problem with the implant and the issue was the result of poor positioning, however, this could not be confirmed without medical records or additional images.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.

Event Description

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

• Brand Name: CUSTOM MADE DEVICE
• Type of Device: CUSTOM TEMPOROMANDIBULAR JOINT REPLACEMENT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17931998
• MDR Text Key: 325626111
• Report Number: 0001032347-2023-00383
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036245481
• UDI-Public: (01)00841036245481(17)230207(10)811110
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

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: 02/07/2023
• Device Model Number: N/A
• Device Catalogue Number: TMJPM-1992
• Device Lot Number: 811110A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 10/13/2023
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2018
• 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
• Patient Outcome(s): Other