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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).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: 0001032347-2021-00322, 0001032347-2021-00323, 0001032347-2021-00324.Medical products: tmj system right standard mandibular component 45mm / 7 hole, part# 24-6545, lot# 539270a.Tmj system right fossa component, small, part# 24-6562, lot# 547100b.Tmj system left fossa component, small, part# 24-6563, lot# 532100b.2.4mm system high torque (ht) cross-drive screw 2.7mm x 8mm, part# 91-2708, lot# ni.2.4mm system high torque (ht) cross-drive screw 2.7mm x 10mm, part# 91-2710, lot# ni.2.4mm system high torque (ht) cross-drive screw 2.7mm x 12mm, part# 91-2712, lot# ni.Tmj system cross drive fossa screw 2.0mm x 9mm, part# 99-6579, lot# ni.2.7mm system emergency cross drive screw, 1/pkg 3.2x8mm, part# 99-9948, lot# ni.2.7mm system emergency cross drive screw, 1/pkg 3.2x10mm, part# 99-9950, lot# ni.
Event or Problem Description
It was reported a patient underwent a revision of bilateral temporomandibular joint implants seven (7) years following implantation due to unknown revision.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being 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 for the mandible and fossa components 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.

• 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: 11990693
• Report Number: 0001032347-2021-00321
• Device Sequence Number: 924035
• Product Code: LZD
• UDI-Device Identifier: 00841036036508
• UDI-Public: (01)00841036036508
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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: 07/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 24-6556
• Device Lot Number: 538170A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 10/15/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention