MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET ARCOM AP PAT W/WIRE 34MM; PROSTHESIS, KNEE

Catalog Number	11-150828
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient was revised for a patellar implant fracture approximately one year, six months post implantation.Attempts for additional information have been made and none has been provided.
Additional Manufacturer Narrative
(b)(4).G2: mexico.The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d5.D10, g3, g6, h1, h2, h3, h4, h6, h10, h11 visual examination of the provided pictures identified a fractured patellar implant.Signs of use, such as rough edges, are present on the component.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Insufficient information provided to perform a compatibility check.Review of complaint history found no additional related issues for this item and the reported part and lot combination.X-rays were provided and reviewed by mmi.The patellar implant is fractured, loose, and displaced medially.Slight lateral subluxation of the patella is observed, but no osseous patellar fracture is identified.The radiologist confirmed loosening and medial displacement of the fractured patellar implant.Femoral rotation of 6.5 degrees could not be confirmed radiographically, and no additional contributing factors to the implant failure were identified.Complaint is confirmed based on provided picture and x rays.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.D10: additional associated products ------------------------------------------------ unk knee femoral lot# unk.Unk knee tibial lot# unk.Unk knee bearing lot# unk.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: BIOMET ARCOM AP PAT W/WIRE 34MM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21708806
• Report Number: 0001825034-2025-00856
• Device Sequence Number: 14616666
• Product Code: HRY
• UDI-Device Identifier: 00887868344336
• UDI-Public: (01)00887868344336(17)271220(10)65750274
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K171054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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 Catalogue Number: 11-150828
• Device Lot Number: 65750274
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Hispanic