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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	06/19/2019
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.It is unknown at this time if the device will be returned for evaluation.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00440, 0001032347-2019-00442, 0001032347-2019-00443.Concomitant medical products ¿ tmj system left fossa component, small, cat# 24-6563, lot# 166460a; tmj system left standard mandibular component, cat# 24-6556, lot# 831890b; "2,4mm" system high torque (ht) cross-drive screw, cat# 91-2710, lot# unk; tmj system cross drive fossa screw, cat# 99-6577, lot# unk.Occupation¿ patient.
Event or Problem Description
It was reported a patient underwent a revision to remove temporomandibular implants on the left side.The implant was removed due to squamous cell carcinoma in the oral cavity.Attempts have been made but no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is non-verifiable.No product was returned; therefore, no functional tests or inspections could be performed.An x-ray was received, however, the x-ray showed a right mandible plate which spanned a gap between the patient's ramus and chin, and was fractured at the chin.Five follow up attempts were made for additional information regarding this implant's identity and scans relating to the left mandible and left fossa components in this complaint file.Tmj tracking confirmed that a left mandible (part# 24-6556, lot# 831890b), left fossa (part# 24-6563, lot# 166460a) and screws (part# 91-2710, 99-6577) were implanted on (b)(6) 2010.The provided x-ray was taken on (b)(6) 2019, prior to removal of the right mandible plate, and a nurse from the hospital confirmed that the right mandible was removed (b)(6) 2019.The x-ray was reviewed by the clinical research team, who concluded there was no evidence indicating that a tmj replacement surgery ever occurred on either side of the patient in the images.The most likely underlying cause cannot be determined.There are no additional indications of manufacturing defects.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
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9173179
• Report Number: 0001032347-2019-00441
• Device Sequence Number: 11395022
• Product Code: LZD
• UDI-Device Identifier: 00841036036508
• UDI-Public: 00841036036508
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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: 07/01/2014
• Device Model Number: N/A
• Device Catalogue Number: 24-6556
• Device Lot Number: 831890B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 10/09/2019
• Supplement Report FDA Received Date: 03/24/2020
• 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