BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSN ASF CR 10MM VE R 3-11 EF

    MDR report key: 23632491 · Received November 24, 2025

    Report

    Report Number
    3007963827-2025-00475
    Event Type
    Injury
    Date Received
    November 24, 2025
    Date of Event
    November 4, 2025
    Report Date
    December 23, 2025
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024241626
    PMA / PMN Number
    K172524
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. UPDATED: B4, B5, D2B, G1, G3, G6, H1, H2, H3, H6, AND H11 NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: HETEROTOPIC BONE AT POSTERIOR MEDIAL JOINT LINE, POSSIBLY EXTENDING INTO THE JOINT. SINCE THIS OSSIFICATION IS APPARENTLY LOCATED POSTERIORLY AND DOES NOT APPEAR TO BE BRIDGING, IT MAY NOT BE CONTRIBUTING TO A FIXED FLEXION DEFORMITY. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT IS NOT CONFIRMED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). G2- AUSTRALIA. H3- CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY THREE YEARS AND FOUR MONTHS POST IMPLANTATION DUE TO JOINT CONTRACTURE AND FLEXION DEFORMITY. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2341694 PSN ASF CR 10MM VE R 3-11 EF PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. 65280591 00889024241626

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R