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

Model Number N/A

Device Problems Insufficient Information (3190); Migration (4003)

Patient Problems Perforation (2001); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Foreign - 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 a revision is planned on an unknown date 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.

Event Description

It was reported that a revision was performed approximately 6 years post implantation due to a perforation of the right ear canal.Additional information is unavailable 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.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The designer of this device, 3d systems, was notified of this complaint and an investigation was conducted.3ds reviewed the scans that were received for planning the replacement device tmjpm-4137.Since the device was explanted, the final position of the mandible implant could not be evaluated.The scans did, however, show dense tissue in the surgical area.It could not be determined what the tissue is composed of, but, according to planning supervisors, this tissue must be removed to implant the new tmjpm device.The dense tissue is close to the tympanic plate, but it cannot be confirmed that it is the cause of ear canal perforation.Review of the dhr shows that the patient scans were within spec and all parts were manufactured properly and approved by qc.Because 3ds was not able to evaluate the implant position and the dhr shows that all parts were manufactured properly, no definitive root cause can 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: 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: 16545119
• MDR Text Key: 311311752
• Report Number: 0001032347-2023-00088
• 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,Followup
• Report Date: 08/11/2023

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: 625230A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female