MAUDE Adverse Event Report: BIOMET MICROFIXATION 50 MM RT STANDARD MANDIBLE; JOINT, TEMPOROMANDIBULAR, IMPLANT

Catalog Number	24-6550
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 was reported the patient underwent an initial right tmj procedure.The patient experienced right facial pain and underwent a revision procedure approximately (4) years post-implantation due to implant fracture.All fragments of the mandible implant were removed and the fossa component was retained.Attempts to obtain additional information have been made.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and/or corrected information.D10 - associated product item #: 24-6562 item name: tmj sm rt fossa comp item lot: 976690a.
Event or Problem Description
It was reported the patient underwent an initial right tmj procedure.The patient experienced right facial pain and underwent a revision procedure approximately four (4) years post-implantation due to implant fracture.All fragments of the mandible implant were removed and the fossa component was retained.Further information was received through patient's medical records which indicated that during the revision procedure, the surgeon excised approximately a 1-centimeter joint granulation tissue mass on the right side.The initial fossa component was retained and the fractured mandibular implant was exchanged without complication.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b5; d4; g3; h1; h3; h4; h5; h6.The reported event was confirmed by review of x-rays and returned product.Review of the provided radiograph confirmed there was approximately 1cm of granulation tissue at the right temporomandibular joint prosthesis that fractured.The right temporomandibular fossa was healing normal.There was a fracture of the right temporomandibular joint prosthesis.The distal segment of the right temporomandibular joint prosthesis was removed, including multiple screws at the distal segment of the prosthesis were totally removed without any complication and identified that there was granulation tissue at the proximal segment of the right temporomandibular joint prosthesis, around the fractures of the mandibular joints there.A new 50mm tmj prosthesis was placed with five screws.Review of the provided radiograph confirmed right temporomandibular joint replacement with fracture through the mandibular plate portion of the implant.Panorex image shows a right temporomandibular joint replacement implant spanning a mandibular ramus osteotomy with resection of the upper ramus and condyle.The mandibular plate fracture is through the second and third from most superior holes; the third from most superior hole contains a screw but the second does not.A visual inspection was conducted on the returned mandible implant.The implant shows signs of use including marking and scratching on the surface.Further review shows that the implant has fractured.The returned mandibular component with three fractures was evaluated utilizing optical microscope and scanning electron microscopy.Sem imaging of fracture surfaces showed excessive smearing and biological debris.Imaging of non-smeared regions at higher magnification revealed fatigue mode of fracture with step-like artifacts and striations.Eds semi-quantitative elemental analysis conducted on the implant fracture surface showed the composition to be consistent with co-cr-mo alloy.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.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: 50 MM RT STANDARD MANDIBLE
• 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: 22992029
• Report Number: 0001032347-2025-00371
• Device Sequence Number: 15725908
• Product Code: LZD
• UDI-Device Identifier: 00841036060343
• UDI-Public: (01)00841036060343(17)230720(10)829310
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2026

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: Lay User/Patient
• Device Expiration Date: 07/20/2023
• Device Catalogue Number: 24-6550
• Device Lot Number: 829310D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2025
• 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: 08/14/2025
• Supplement Date Received by Manufacturer: 11/05/2025; 01/07/2026
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 12/02/2025; 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2018
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 84 KG