BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANGUARD ROCC POR FEM S60 L

    MDR report key: 24244737 · Received February 3, 2026

    Report

    Report Number
    3002806535-2026-00048
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Date of Event
    January 30, 2025
    Report Date
    February 3, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    UDI-DI
    03599870105344
    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 PRODUCT IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO 00889024230347. 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 K172524. PRODUCT WAS RECEIVED. PERFORMED A VISUAL INSPECTION OF PACKAGING AND LABELING FOR THE ITEM. OUTER PACKAGING WAS NOT RETURNED ONLY THE INNER TRAY AND CONFIRMING COMPLAINT IS CRACKED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, WHEN OPENING THE STERILE BLISTER OF THE FEMORAL IMPLANT, IT WAS NOTICED THAT THE STERILE PACKAGING WAS CRACKED. THE OPERATION WAS COMPLETED WITH ANOTHER IMPLANT OF THE SAME SIZE AND THERE WERE NO CONSEQUENCES OR HEALTH IMPACTS TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT. UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT WAS EARLIER REPORTED UNDER THE INCORRECT MFR NUMBER (3006946279 -2025 -00022).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310759 VANGUARD ROCC POR FEM S60 L KNEE PROSTHESIS JWH BIOMET UK LTD. 0001640436 03599870105344

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown