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

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/19/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem Description
No further event information available at the time of this report.
Additional 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
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10944356
• Report Number: 0001032347-2020-00598
• Device Sequence Number: 14255723
• Product Code: LZD
• UDI-Device Identifier: 00841036036508
• UDI-Public: 00841036036508
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention