MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT 50MM / 9 HOLE; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994); Loss of Range of Motion (2032)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00096.Concomitant medical products: tmj system right fossa component, small, part# 24-6562, lot# 905330d.Unknown mandible screw, part# ni, lot# ni.Unknown fossa screw, part# ni, lot# ni.Initial reporter occupation ¿ patient.
Event or Problem Description
It was reported the patient underwent a procedure to remove heterotopic bone growth one (1) year following implantation of temporomandibular joint implants on the right side due to pain, heterotopic ossification and closed lock jaw.It was reported that the patient is attending a follow up appointment to discuss the possibility of a revision to receive custom temporomandibular joint implants two (2) years following implantation of temporomandibular joint implants on the right side.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h6, h10 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history records will not be reviewed as part of this investigation because it was determined that there was no problem with the devices and the reported issue was attributed to the patient's condition.No problems were found with the devices and it was determined the root cause of the reported issue is attributed to the patient condition.Per hcp review, the patient's complications are ongoing as a result of the initial injury causing patient anatomy issues (bone overgrowth) which is then leading to pain and issues with motion.There does not appear to be any complications with the device which is being considered for revision after serving its intended purpose.Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.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 RIGHT STANDARD MANDIBULAR COMPONENT 50MM / 9 HOLE
• 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 delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 11405111
• Report Number: 0001032347-2021-00095
• Device Sequence Number: 14521750
• Product Code: LZD
• UDI-Device Identifier: 00841036060343
• UDI-Public: (01)00841036060343(17)240722(10)907260
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

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: 07/22/2024
• Device Model Number: N/A
• Device Catalogue Number: 24-6550
• Device Lot Number: 907260D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2019
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female