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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).G2: foreign - canada.D10: medical product - zimmer biomet screw catalog #: unknown lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2024-00103.

Event Description

It was reported a patient had a bilateral tmj procedure approximately six years ago.Subsequently, the patient developed pain and swelling and approximately four years ago, underwent a biopsy and revision of a few screws.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2; h3; h6; h11.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.The design of the device was reviewed by the design vendor.Review of the dhr shows that all parts were planned, designed, and manufactured conforming to internal procedures.Planned screw placement was reviewed and it appears that sufficient bony contact and registration for screws to hold the implants in place.With the information provided, no further investigation can be completed.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot 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.

• Brand Name: CUSTOM MADE DEVICE
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• 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: 18968078
• MDR Text Key: 338482757
• Report Number: 0001032347-2024-00102
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036241643
• UDI-Public: (01)00841036241643(17)221121(10)804330
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2022
• Device Model Number: N/A
• Device Catalogue Number: TMJPM-1955
• Device Lot Number: 804330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 06/13/2024
• Supplement Dates FDA Received: 06/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2017
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female