BEUDAMED
    FDA Adverse Event Other Summary report: N

    HRHK TIB ROT COMP LRG/XLRG

    MDR report key: 1622436 · Received February 19, 2010

    Report

    Report Number
    9610726-2010-00059
    Event Type
    Other
    Date Received
    February 19, 2010
    Date of Event
    January 21, 2010
    Report Date
    January 21, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    KRO
    PMA / PMN Number
    K031480
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED. IF DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "NATIONAL LOANER BANK EAST AND NATIONAL LOANER BANK WEST COMBINED INSTRUMENTS/IMPLANTS FOR CASE. THE IMPLANTS WERE RECEIVED MISSING A CASE WORTH OF IMPLANTS. THE RESTOCK WAS TO COME IN THE DAY OF SURGERY. THERE WERE FEDEX SHIPPER DELAYS THE DAY OF SURGERY. NATIONAL LOANER BANK RECEIVED ONLY PAGE 1 OF 2 FOR THE RESTOCK REQUEST AND THUS THE RESTOCK ARRIVED MISSING THE PART # (B)(4) ALONG WITH 4 OTHER PARTS. THE DOCTOR IMPLANTED A SIZE STD FEMUR, A S2 BASEPLATE, SM 10 MM INSERT WITH A L-XL MRH KNEE TIBIAL ROTATING COMPONENT PART #(B)(4). THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HRHK TIB ROT COMP LRG/XLRG IMPLANT KRO STRYKER ORTHOPAEDICS LIMERICK NA J77903

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other