BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA MC VE ASF R 11MM 8-11/GH

    MDR report key: 23906080 · Received December 29, 2025

    Report

    Report Number
    3007963827-2025-00540
    Event Type
    Injury
    Date Received
    December 29, 2025
    Date of Event
    December 10, 2025
    Report Date
    May 28, 2026
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    MBH
    UDI-DI
    00889024468504
    PMA / PMN Number
    K150090
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED : B3; B4; B5; D2; E1; G1; G3; G6; H1; H2; H10. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 42522100911 - PSN MC VE ASF R 11MM 8-11/GH - 65336417. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED WITH RANGE OF MOTION POSTOPERATIVELY ACHIEVED AT 0-130° WITH NO COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, AT A FOLLOW UP APPOINTMENT APPROXIMATELY 6 WEEKS POST-OP, THE PATIENT HAD A FLEXION CONTRACTURE WITH A RANGE OF MOTION OF 21-93 DEGREES AND UNDERWENT A MANIPULATION UNDER ANESTHESIA. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2505808 PERSONA MC VE ASF R 11MM 8-11/GH PROSTHESIS, KNEE MBH ZIMMER ORTHOPAEDIC MFG. LTD. 65336417 00889024468504

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H SEE H11.