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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint: (b)(4).Concomitant medical products: zimmer biomet tmj system right standard mandibular component, catalog # : 24-6545, lot #: 190800; zimmer biomet tmj system left standard mandibular component, catalog #: 24-6546, lot #: 143340; zimmer biomet tmj system left fossa component, medium, catalog #: 24-6561, lot #: 071560; unknown screws, catalog#: ni, lot#: ni.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: 0001032347-2019-00312, 0001032347-2019-00313, 0001032347-2019-00314.

Event Description

It was reported that a revision was performed in which the tmj implants were removed and replaced with new implants eleven years post-implantation.Attempts have been made and no further information has been provided.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Since there was a revision to remove and replace these parts, the complaint is confirmed.There are no indications of manufacturing defects.No product was returned and no functional tests or inspections could be performed.There are no indications of manufacturing defects.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: TMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8679537
• MDR Text Key: 147352105
• Report Number: 0001032347-2019-00315
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036036560
• UDI-Public: 00841036036560
• Combination Product (y/n): N
• PMA/PMN Number: P020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2012
• Device Model Number: N/A
• Device Catalogue Number: 24-6562
• Device Lot Number: 284560
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2019
• 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