MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SMALL LEFT FOSSA COMPONENT; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).D10: medical product - zimmer biomet right standard mandibular component catalog #: 24-6545 lot #: 756830a, zimmer biomet small right fossa component catalog #: 24-6562 lot #: 764950a, zimmer biomet left standard mandibular component catalog #: 24-6546 lot #: 726470a, zimmer biomet small left fossa component catalog #: 24-6563 lot #: 638910a.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it 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 reports: 0001032347-2023-00312, 0001032347-2023-00313, 0001032347-2023-00314.

Event Description

It was reported that the patient has metal sensitivity and is experiencing pain.No further intervention has been reported.Attempts have been made and no further information has been provided.

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.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: TMJ SMALL LEFT FOSSA COMPONENT
• 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: 17499846
• MDR Text Key: 320794114
• Report Number: 0001032347-2023-00315
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036036584
• UDI-Public: (01)00841036036584(17)200930(10)638910
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 24-6563
• Device Lot Number: 638910A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2020
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other