MAUDE Adverse Event Report: BIOMET MICROFIXATION UNKNOWN LEFT FOSSA; TEMPOROMANDIBULAR JOINT REPLACEMENT

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that a revision is planned on an unknown date due to an unknown reason.However, no revision procedure has been reported to date.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Medical product - zimmer biomet left mandible catalog #: unk lot #: unk.Report source: foreign - united kingdom.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2023-00016.

Manufacturer Narrative

This report was submitted in error.The event was previously reported in 0001032347-2022-00075.

Event Description

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

• Brand Name: UNKNOWN LEFT FOSSA
• Type of Device: TEMPOROMANDIBULAR 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: 16136946
• MDR Text Key: 307073760
• Report Number: 0001032347-2023-00017
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• 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: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN LEFT FOSSA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention