BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KRH DURATION STANDARD BUMPER

    MDR report key: 3222685 · Received July 12, 2013

    Report

    Report Number
    0002249697-2013-02270
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K972863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT 64753940, LOT TDAC616, DESCRIPTION: KRH STANDARD AXLE; CAT 64852460, LOT TCPC929, DESCRIPTION: KRH DURATION BUSHING STANDARD; CAT 64753933, LOT MVEP, DESCRIPTION: TIBIAL COMP KIN HINGE KNEE. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. PRODUCT NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION FOR AN UNSPECIFIED REASON INVOLVING A KRH BUMPER COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS THE DEVICE WAS NOT RETURNED. DHR REVIEW FOR THE REPORTED LOT WAS SATISFACTORY. CHR REVIEW FOR THE REPORTED LOT CONFIRMED THAT THERE WERE NO OTHER SIMILAR REPORTED EVENTS. THE REPORTED SECOND REVISION SURGERY IS CONFIRMED BASED ON THE IMPLANT SHEET THAT WAS PROVIDED, HOWEVER, THE REASON FOR THE REVISION IS UNKNOWN. IT IS LIKELY THAT THE PROCEDURE IS ASSOCIATED WITH A ROUTINE REVISION PROCEDURE FOR REPLACEMENT OF POLY AND METAL BEARING COMPONENTS APPROXIMATELY 10 YEARS AFTER THE FIRST REVISION SURGERY INVOLVING EXCHANGE OF THE SAME COMPONENTS. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    AFTER RECEIVED IMPLANT SHEETS IT WAS DISCOVERED THAT THE PATIENT HAD A COMPONENTS IMPLANTED ON (B)(6) 2003 AND A REVISION ON (B)(6) 2012. THE PATIENT HAD A PRIMARY SURGERY ON (B)(6) 1993.

    Description of Event or Problem · 1

    AFTER RECEIVED IMPLANT SHEETS IT WAS DISCOVERED THAT THE PATIENT HAD A COMPONENTS IMPLANTED ON (B)(6) 2003 AND A REVISION ON (B)(6) 2012. THE PATIENT HAD A PRIMARY SURGERY ON (B)(6) 1993.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323670 KRH DURATION STANDARD BUMPER IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH TCPC413

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R