MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LFT STANDARD TI 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	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a tmj arthroplasty.Subsequently, the patient is being considered for a tmj-pmi inlay product on an unknown date due to strong pain on the left side.The surgeon is requesting an overlay.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).D10 ¿ medical products: item #24-6561i, lot # 013210b; tmj system med left fossa component item # tmjpm-2397, lot #968200a; custom right pm-tmj & model g2: foreign: france.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records/radiographs were provided and reviewed by the designer, 3d systems.Review of the available records identified the following: left joint overlay: the tmj components on the patient¿s left side are positioned differently from what was planned.This may have affected the patient¿s occlusion and the position of the components on the patient¿s right side.The fossa component is approximately 4.5mm more posterior than what was planned.The component is also rotated away from frankfurt horizontal.The mandible component is approximately 5mm more posterior than what was planned.The component is also misaligned from the center of the fossa cup.The left fossa post-op appears as though the most posterior fossa screw on the left side may be intruding into the patient¿s brain cavity.The right joint overlay: the tmj components on the patient¿s right side are positioned differently from what was planned.This may have affected the patient¿s occlusion and the position of the components on the patient¿s left side.The fossa component is approximately 2mm more anterior than what was planned.The component is also rotated away from frankfurt horizontal.The root cause of the reported issue is attributed implants not placed in planned position.The design of the device was reviewed by the designer, 3d systems: three years after implementation of the tmjpm, the patient was complaining of pain on their left side.Overlays of pre- and post-operative scans revealed the tmj protheses are not in the planned position.The overlay report shows that the patient¿s occlusion is not in the planned position, and a screw minimally penetrates the patient's brain cavity, which was caused by misplacement of the fossa implant.Review of the case shows that all parts were properly designed, and, in the proper position the screws posed no risk of penetrating the brain cavity.The reported event is confirmed.A summary of the investigation was sent to the surgeon.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2023-00200 and 0001032347-2023-00350.

• Brand Name: TMJ SYSTEM LFT STANDARD TI MANDIBULAR COMPONENT
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17667608
• Report Number: 0001032347-2023-00133
• Device Sequence Number: 17723390
• Product Code: LZD
• UDI-Device Identifier: 00841036081713
• UDI-Public: (01)00841036081713(17)231030(10)858220
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2023

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: 10/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 24-6546TI
• Device Lot Number: 858220A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown