BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSN ASF CR 10MM VE L 3-11 EF

    MDR report key: 23720335 · Received December 4, 2025

    Report

    Report Number
    3007963827-2025-00489
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 12, 2025
    Report Date
    April 28, 2026
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024235113
    PMA / PMN Number
    K172524
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. UPDATED: B4, B5, D2B, D9, G1, G3, G6, H1, H2, H3, H6, AND H11. CORRECTED: H6 (DEVICE CODE). VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE DOVETAIL FEATURE IS DAMAGED, BOTH SIDES FLARED AND COMPRESSED. THE ART SURFACE HAS MINOR DAMAGE SUCH AS SURFACE SCRATCHES. THE EXTRACTOR SLOT AND NON-ARTICULATING SURFACES ALSO EXHIBIT NICKS AND GOUGES. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE ROOT CAUSE IS ATTRIBUTED TO USE ERROR. DAMAGE TO THE ARTICULAR SURFACE CAN OCCUR IF THE ARTICULAR SURFACE IS NOT CORRECTLY PLACED AND ORIENTED BEFORE PUSHING IT USING THE INSERTER INSTRUMENT. THIS COMPLAINT IS 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- JAPAN. H3.: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL 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 THE ARTICULAR SURFACE DIDN¿T FIT IN TIBIAL PLATE. IT WAS REPORTED THAT DESPITE MULTIPLE ATTEMPTS TO INSERT THE ARTICULAR SURFACE WHILE CAREFULLY CONSIDERING THE INSERTION DIRECTION, IT DID NOT GO IN. UPON CHECKING THE SHAPE OF THE SURFACE, IT APPEARED DEFORMED. THEREFORE, A NEW ARTICULAR SURFACE WAS OPENED AND USED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143815 PSN ASF CR 10MM VE L 3-11 EF PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. 67220437 00889024235113

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown