MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM RIGHT FOSSA COMPONENT, MEDIUM; 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
Zimmer biomet complaint (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: 0001032347-2021-00088 concomitant medical products tmj system right standard titanium mandibular component 55mm / 12 hole, part# 24-6555ti, lot# 602500a unknown mandible screw, part# ni, lot# ni unknown fossa screw, part# ni, lot# ni reporter: patient.
Event or Problem Description
It was reported the patient will require a revision at a future unspecified date due to various issues five (5) years following implantation of temporomandibular joint implants on the right side.The patient indicates that they have sarcoidosis with unknown etiology and they are unable to take a metal allergy test due to taking high doses of steroids that may produce a false negative.Increasing levels of pain led to a ct scan which indicated heterotopic ossification around the implant.A revision and replacement with custom devices is planned at a future unspecified date.Attempts have been made and no further information has been provided.
Event or Problem Description
It was reported the patient will undergo a revision in a few weeks due to increasing pain and limited range of motion five (5) years following implantation of temporomandibular joint implants on the right side.The patient indicates that they have sarcoidosis with unknown etiology and they are unable to take a metal allergy test due to taking high doses of steroids that may produce a false negative.A ct scan indicated heterotopic ossification around the implant.The patient has almost no jaw movement.A bilateral revision and replacement with custom devices is planned.It was reported that no further information is available.
Additional Manufacturer Narrative
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.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.
Additional Manufacturer Narrative
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
It is further reported that the patient was being treated for an immune response to one of the alloys in the implant and was hospitalized for several months in 2017.The patient underwent a bilateral revision in (b)(6) of 2021 and was implanted with a competitor's product.The patient is currently being monitored by rheumatology, pulmonology, nephrology, endocrinology and ophthalmology neurology specialist and is seen every three months.The patient also continues to be treated with methotrexate inj, humira inj, hydro chloroquine, prednisone, inhalers and blood pressure medications to keep down blood pressure due to kidney and organ damage.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to update additional information in section b4, b5, e1, e2, e3, g3, g6, h2, h6 and h10.The additional information provided does not change the previously completed investigation.The root cause of the reported issues remains unknown.

• Brand Name: TMJ SYSTEM RIGHT FOSSA COMPONENT, MEDIUM
• 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: 11398530
• Report Number: 0001032347-2021-00089
• Device Sequence Number: 19626184
• Product Code: LZD
• UDI-Device Identifier: 00841036036522
• UDI-Public: (01)00841036036522(17)210108(10)653760
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/24/2022

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: 01/08/2021
• Device Model Number: N/A
• Device Catalogue Number: 24-6560
• Device Lot Number: 653760A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 02/28/2021; 10/25/2021; 05/19/2022; 08/16/2022
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 03/22/2021; 11/15/2021; 06/13/2022; 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2016
• 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: Required Intervention
• Patient Sex: Male