MAUDE Adverse Event Report: BIOMET MICROFIXATION CUSTOM MADE DEVICE COENEN PM-TMJ & MODEL; CUSTOM DEVICE

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Bacterial Infection (1735); Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The device has been returned for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: unknown screws, part# unk, lot# unk.The user facility is foreign; therefore a facility medwatch report will not be available.Report source: (b)(6).

Event Description

It was reported a custom temporomandibular joint prosthesis caused an oral perforation and infection approximately two years post-operatively.It was believed that the implant was too large.A revision was performed wherein the implant was modified by grinding the mandible component in an effort to improve the fit.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed.The mandible component was returned for evaluation.Upon review, it can be seen that there is damage to the anterior section of the base plate that is consistent with the distributors report of the prior grinding of the implant.There are also minor scratches consistent with the explantation of the device.No further anomalies could be found with the explanted complaint product.The dhr of this product was reviewed and no non-conformance was found.This is a custom device with no similar devices and the lot quantity is one.Therefore, there are no similar complaints and the risks associated with this device are unique to this device.The most likely underlying cause of the complaint is the patient's condition of complex anatomy and heterotopic bone formation.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.

Event Description

This follow-up report is being submitted to relay additional information.

• Brand Name: CUSTOM MADE DEVICE COENEN PM-TMJ & MODEL
• Type of Device: CUSTOM DEVICE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9723283
• MDR Text Key: 188494240
• Report Number: 0001032347-2020-00113
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2020
• Device Model Number: N/A
• Device Catalogue Number: TMJPM-1083
• Device Lot Number: 627360A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 36 YR