BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRS FEM ROT HNGE LFT 65MM BOD

    MDR report key: 3205522 · Received July 3, 2013

    Report

    Report Number
    0002249697-2013-02220
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K972401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 2481-3-040, LOT # UNK DESCRIPTION: MRS FEM W/MALE-FE TAPER 40 BD CAT # 6475-3-933, LOT # UNK DESCRIPTION: TIBIAL COMP KIN HINGE KNEE CAT # 6475-3-940, LOT # UNK, DESCRIPTION: KRH STANDARD AXLE; CAT # 6475-3-942, LOT # UNK, DESCRIPTION: KRH BUMPER; CAT # 6475-3-944, LOT # UNK, DESCRIPTION: KRH BUSHING STANDARD; CAT # 6475-3-946, LOT # UNK, DESCRIPTION: TIB/BEARING 8MM THICK FOR; CAT # 6475-3-956, LOT # UNK, DESCRIPTION: TIB/BEARING 16MM THICK FOR; CAT # 2475-3-492, LOT # UNK, DESCRIPTION: KRH KNEE REDUCED HT. BUMPER 6MM. AT THIS TIME, IT CANNOT BE DETERMINED IF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. EXPLANTED 10 YEARS AGO.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS 64 INCHES IN HEIGHT. AN EVENT REGARDING REVISION FOR AN UNSPECIFIED REASON INVOLVING AN MRS FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE REPORTED 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 COMPONENTS A 10 YEARS AFTER THE ORIGINAL SURGERY. FURTHER RELEVANT INFORMATION SUCH AS X-RAYS, OPERATIVE REPORTS, PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306181 MRS FEM ROT HNGE LFT 65MM BOD IMPLANT KRO STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention