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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
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.The device will not be returned for evaluation as it remains implanted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00455, 0001032347-2019-00457, 0001032347-2019-00458, 0001032347-2019-00459, 0001032347-2019-00460.Medical products: tmj system left fossa component small, cat# 24-6563, lot# 661630; tmj system left standard mandibular component, cat# 24-6551, lot# 703160; "2.4mm" system high torque (ht) cross-drive screw, cat# 91-2708, lot# unk; "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; tmj system cross drive fossa screw, cat# 99-6579, lot# unk.Occupation: patient¿s grandmother and caregiver.
Event or Problem Description
It was reported that a crack in the patient's temporomandibular implant was discovered by x-ray following wisdom teeth extraction.The patient was involved in a motorcycle accident in (b)(6) 2018 that resulted in significant bodily trauma and mental impairment.The device remains implanted and there is no plan at this time for removal.No additional patient consequences were reported.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
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.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.For all non-custom tmj mandibular implants in the previous one year (from the notification date) involving the implant fracturing, there is a complaint rate of (b)(4) which is no greater than the occurrence listed in the afmea.The most likely underlying cause of the complaint could not be determined, though it is possible that the fracture is related to patient activity.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 LEFT STANDARD MANDIBULAR COMPONENT
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9177373
• Report Number: 0001032347-2019-00456
• Device Sequence Number: 17040866
• Product Code: LZD
• UDI-Device Identifier: 00841036060329
• UDI-Public: 00841036060329
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2010
• Device Model Number: N/A
• Device Catalogue Number: 24-6551
• Device Lot Number: 703160
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 02/20/2020
• 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: Required Intervention