MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT 55MM / 12 HOLE; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problem Migration (4003)

Patient Problem No Information (3190)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001032347-2020-00596, 0001032347-2020-00597, 0001032347-2020-00599.Medical products: tmj system right standard mandibular component 50mm / 9 hole, part# 24-6550, lot# 851360.Tmj system right fossa component, medium, part# 24-6560-int, lot# 934560.Tmj system left standard mandibular component 55mm / 12 hole, part# 24-6556, lot# 790490.Tmj system left fossa component, small, part# 24-6563-int, lot# 934590.Unknown screws, part# ni, lot# ni.The user facility is foreign; therefore, a facility medwatch report will not be available.Foreign report source: (b)(6).

Event Description

It was reported the patient will undergo a revision and replacement of temporomandibular joint implants on the right side due to displacement.The mandible component is displaced laterally out of the fossa component.The devices will be replaced with a custom implant.It was reported that no further information is available.

Event Description

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

Manufacturer Narrative

Upon receiving additional information of the reported event, it was determined to be not reportable.The product id originally reported was incorrect and the patient did not have implanted devices on the left side.The initial report should be voided.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: TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT 55MM / 12 HOLE
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10944356
• MDR Text Key: 219498166
• Report Number: 0001032347-2020-00598
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036036508
• UDI-Public: 00841036036508
• Combination Product (y/n): N
• PMA/PMN Number: P020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2010
• Device Model Number: N/A
• Device Catalogue Number: 24-6556
• Device Lot Number: 790490
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2021
• 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