BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANGUARD ROCC POR FEM S57.5 L

    MDR report key: 24143683 · Received January 22, 2026

    Report

    Report Number
    3002806535-2026-00023
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    April 24, 2025
    Report Date
    January 22, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    MBH
    UDI-DI
    03599870105337
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO 00889024229655. G2 ¿ FOREIGN ¿ JAPAN. G4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K122745. VISUAL INSPECTION OF THE PICTURES PROVIDED SHOWS A CRACK ON ONE SIDE OF THE BLISTER THAT CONFIRMS THE EVENT. PERFORMED A VISUAL INSPECTION OF PACKAGING AND LABELING. OUTER PACKAGING (PRODUCT CARTON/BOX) EXHIBITS NO DAMAGE. INSPECTED INNER PLASTIC TRAY/CAVITY, CONFIRMING COMPLAINT IS CRACKED. TRAY/CAVITY DAMAGE WAS NOT TRANSFERRED THROUGH THE CARTON/BOX. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. REPORTED EVENT DID OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE, BUT REVIEW OF THE MEDICAL RECORDS HAS NOT BEEN PERFORMED, AS THE EVENT IS NOT RELATED TO THE MEDICAL PROCEDURE. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY, THE SURGEON NOTICED THAT THE OUTER PLASTIC CASE OF THE IMPLANT WAS DAMAGED. THE SURGEON ONLY NOTICED THIS DAMAGE AFTER THE IMPLANT WAS REMOVED FROM THE PACKAGING, THEREFORE COULD NOT BE SURE IF THE STERILITY WAS COMPROMISED. THE SURGERY WAS COMPLETED WITH ANOTHER IMPLANT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT WAS EARLIER REPORTED UNDER THE INCORRECT MFR NUMBER (3006946279-2025-00055).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204972 VANGUARD ROCC POR FEM S57.5 L KNEE PROSTHESIS MBH BIOMET UK LTD. 0001700628 03599870105337

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown