BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KRH STANDARD AXLE

    MDR report key: 2871971 · Received December 6, 2012

    Report

    Report Number
    9610726-2012-00386
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K792089
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: DESCRIPTION: KRH DURATION STANDARD BUMPER, CAT #6485-4-100, LOT #UNK; DESCRIPTION: KRH DURATION BUSHING STANDARD, CAT #6485-2-460, LOT #UNK; DESCRIPTION: MRH +OVER TIB BEAR LONG XS/XL, CAT #6481-2-103, LOT #036483A; DESCRIPTION: MRH AXLE, CAT #6481-2-120, LOT #CTD1083; DESCRIPTION: MRHK FEMORAL BUSHING, CAT #6481-2-110, LOT #M5T08.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON REVISED PT'S RIGHT KNEE, A (B)(6) KINEMATIC ROTATING HINGE WITH A CUSTOM DISTAL FEMORAL COMPONENT. SURGEON TOOK OUT THE AXLE AND BUSHINGS AND DID NOT HAVE PROPER COMPONENTS AVAILABLE TO COMPLETE THE CASE SO SURGEON INSTALLED MRH COMPONENTS IN PT AND HAD CORRECT COMPONENTS FLOWN IN TO COMPLETE THE CASE WITH PROPER COMPONENTS 6 HOURS AFTER REMOVAL. THE REASON FOR THE REVISION WAS WORN OUT COMPONENTS AND PT WAS EXPERIENCING SOME PAIN. THE ORIGINAL HINGE WAS RE-IMPLANTED AS A NEW HINGE WAS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KRH STANDARD AXLE IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention