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

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Fluid Discharge (2686); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Explant date - 2021.Report source - united kingdom.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient's right side implants were removed approximately 6 years post implantation due to an unknown reason.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.B3 and d6b - unknown date in march 2021.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, implanted products are not identified as the source or contributing to the reported infection.Therefore, this event is no longer considered reportable and the initial medwatch should be voided.

Event Description

It was further reported that the patient underwent a revision procedure due to discharge from the right ear showing fungal infection.

• Brand Name: CUSTOM MADE DEVICE
• Type of Device: CUSTOM TEMPROMANDIBULAR 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: 16545188
• MDR Text Key: 311308564
• Report Number: 0001032347-2023-00089
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036194925
• UDI-Public: (01)00841036194925(17)190601(10)625230
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Model Number: N/A
• Device Catalogue Number: TMJPM-1111
• Device Lot Number: 625230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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): Required Intervention; Hospitalization