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

Model Number N/A

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2020

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet (b)(4).The device will not be returned for analysis as it was implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Medical products unknown screws, part# ni, lot# ni.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source ¿ (b)(6).

Event Description

It was reported the custom bilateral temporomandibular joint implants did not fit properly and were difficult to implant resulting in an eight (8) hour surgery.The surgeon reports the condylar heads are inferior to the fossa on both sides.No additional patient consequences have been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h6; h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records for the tmjpm devices identified no deviations or anomalies during manufacturing.Part and lot identification are necessary for review of device history records, neither were provided for the screws.Medical records were not provided.The root cause of the reported issue is attributed to the positioning of the fossa components on both the left and ride side.The designer of this device, 3ds, conducted an investigation into the reported issue.The patient's post-operative scans were reviewed and it was identified that the fossa fits deviated from the planned positions.The left side fossa had the posterior screw in the correct position, but the anterior screw was implanted inferiorly from the planned position.The right side fossa was implanted superiorly from the planned position.A post-op meeting was held with the surgeon and the design vendor on 18 feb 2021 to discuss the investigation and root cause.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 FISHER PM-TMJ & MODEL
• Type of Device: CUSTOM MADE DEVICE
• 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 delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 10999088
• MDR Text Key: 221228914
• Report Number: 0001032347-2020-00614
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/10/2021

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 Model Number: N/A
• Device Catalogue Number: TMJPM-3075
• Device Lot Number: 009360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2020
• Initial Date FDA Received: 12/13/2020
• Supplement Dates Manufacturer Received: 12/01/2020
• Supplement Dates FDA Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2020
• 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 Sex: Female