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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	09/11/2020
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: 0001032347-2020-00227, 0001032347-2020-00456, 0001032347-2020-00458.Implantation date was in 2010.Tmj system left fossa component, medium, part# 24-6561, lot# 080260 tmj system right fossa component, medium, part# 24-6560-int, lot# 725240 tmj system left standard mandibular component 55mm / 12 hole, part# 24-6556, lot# 205450 tmj system right standard offset mandibular component 50mm / 9 hole, part# 24-6650-int, lot# 489880.Unknown screws, part# ni, lot# ni.(b)(6).User facility is foreign; therefore, a facility medwatch report will not be available.Report source: (b)(6).
Event or Problem Description
It was reported the patient underwent a bilateral revision of temporomandibular joint implants ten (10) years following implantation due to ankylosis and patient discomfort.The stock implants were replaced with a custom device.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is considered confirmed because a revision surgery was reported.No product was returned; therefore, no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.The non-conformance database was reviewed for the mandible component; no non-conformances were found.There are no indications of manufacturing defects.This is the only complaint for this item# 24-6556, lot# 205450.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding revision due to ankyloses, there is a complaint rate of 0.07%, which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint is due to a patient condition.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 or Problem Description
This follow-up report is being submitted to relay additional information.

• 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: 10576489
• Report Number: 0001032347-2020-00457
• Device Sequence Number: 14449313
• Product Code: LZD
• UDI-Device Identifier: 00841036036508
• UDI-Public: 00841036036508
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2020

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: 12/01/2011
• Device Model Number: N/A
• Device Catalogue Number: 24-6556
• Device Lot Number: 205450
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 10/26/2020
• 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
• Patient Age: 41 YR