MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	09/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The investigation is in process.It is unknown at this time if the device will be returned for evaluation.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: 0001032347-2019-00471, 0001032347-2019-00472, 0001032347-2019-00473, 0001032347-2019-00474, 0001032347-2019-00475, 0001032347-2019-00476.Medical products: tmj system left standard mandibular component, part# 24-6551, lot# 516390a, tmj system left standard mandibular component, part# 24-6556, lot# 509470b, tmj system left fossa component small, part# 24-6563, lot# 523730a, 2.4mm system high torque (ht) cross-drive screw, part# 91-2710, lot# unknown, 2.4mm system high torque (ht) cross-drive screw, part# 91-2712, lot# unknown, tmj system cross drive fossa screw, part# 99-6577, lot# unknown, tmj system cross drive fossa screw, part# 99-6579, lot# unknown.
Event or Problem Description
It was reported the patient underwent a revision to remove temporomandibular implants due to an unknown reason.Attempts have been made to gather more information but none has been provided.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.As a revision surgery was reported, the complaint is confirmed.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 dhr for the mandible component was reviewed.Nc5815 was opened to document the rework of one 24-6551 from this lot that was found to have scuff marks.The reworked component passed quality inspection.There are no indications of manufacturing defects.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding pain leading to a revision surgery, there is a complaint rate of 0.438%, which is no greater than the occurrence listed in the afmea.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding dislocation, there is a complaint rate of 0.255%, which is no greater than the occurrence listed in the afmea.This is the only complaint regarding pain and dislocation leading to a revision surgery for part# 24-6551 lot# 516390a.The most likely underlying cause of the complaint could not 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.The following fields were updated: b4 date of this report.B5 describe event or problem.D4 expiration date.D10 device availability.G4 date received by manufacturer.G7 type of report.H2 follow up type.H3 device evaluated by manufacturer.H3 device manufacturer date.H6 patient code.H6 device code.H6 method code.H6 results code.H6 conclusions code.H10 additional narratives/data.
Event or Problem Description
This follow-up report is being submitted to relay additional information.It was reported the patient complained of pain and open lock jaw approximately four months prior to the revision surgery.A surgical exploration and joint replacement was performed, and the surgeon noted there were no visible defects to the hardware, just a lot of scar tissue.

• Brand Name: TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9241959
• Report Number: 0001032347-2019-00470
• Device Sequence Number: 145845
• Product Code: LZD
• UDI-Device Identifier: 00841036060329
• UDI-Public: 00841036060329
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

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: 02/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 24-6551
• Device Lot Number: 516390A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 03/23/2020
• 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