MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT 45MM / 7 HOLE; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis as it remains implanted; 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 reports: 0001032347-2020-00345, 0001032347-2020-00346, 0001032347-2020-00347, 0001032347-2020-00348, 0001032347-2020-00349, 0001032347-2020-00350, 0001032347-2020-00351.Concomitant medical products tmj system right standard mandibular component 45mm / 7 hole, part# 24-6545, lot# 847590; tmj system left standard mandibular component 45mm / 7 hole, part# 24-6546, lot# 847580; tmj system right fossa component, medium, part# 24-6560, lot# 824640; tmj system left fossa component, medium, part# 24-6561, lot# 824650; tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# ni; tmj system cross drive fossa screw 2.0mm x 9mm, part# 99-6579, lot# ni; 2.7mm system cross drive screw, 1/pkg 2.7 x 8.0mm, part# 99-9908, lot# ni; 2.7mm system emergency cross drive screw, 1/pkg 3.2x8mm, part# 99-9948, lot# ni.Initial reporter - patient.
Event or Problem Description
It was reported by the patient that she had an operation to clean out her joint approximately nine (9) years following implantation of bilateral temporomandibular joint implants.No additional patient consequences have been reported.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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.

• Brand Name: TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT 45MM / 7 HOLE
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10364349
• Report Number: 0001032347-2020-00344
• Device Sequence Number: 2888302
• Product Code: LZD
• UDI-Device Identifier: 00841036036430
• UDI-Public: 00841036036430
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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: 10/18/2007
• Device Model Number: N/A
• Device Catalogue Number: 24-6545
• Device Lot Number: 847590
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 08/11/2021
• 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