BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE CROSSOVER

    MDR report key: 4093964 · Received September 16, 2014

    Report

    Report Number
    0002249697-2014-03520
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K972863
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE AND MANUFACTURING DATE CORRECTED. AN EVENT REGARDING A FRACTURED DEVICE INVOLVING A REVERSE CROSSOVER COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO DEVICES WERE RETURNED OR MADE AVAILABLE FOR EVALUATION. MEDICAL EVALUATION NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. DEVICE HISTORY REVIEW WAS SATISFACTORY. COMPLAINT HISTORY REVIEW INDICATES THAT THERE ARE NO OTHER SIMILAR EVENTS FOR THE LOT. THE REPORTED EVENT WAS NOT CONFIRMED. IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE FOR THIS CASE AS NO MEDICAL RECORDS OR EXPLANTED COMPONENTS WERE PROVIDED FOR THIS INVESTIGATION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME TO THE SURGEON IN (B)(6) 2014 WITH A PATELLA FRACTURE. HE WAS SCHEDULED FOR A PATELLECTOMY. THE SURGEON'S PLAN DURING SURGERY WAS TO CHANGE THE TIBIAL POLY BEARINGS, BUSHINGS AND BUMPER. DURING SURGERY IT WAS NOTED THAT THE MEDIAL SIDE OF THE TIBIAL BEARING HAD BROKEN OFF AND THE FEMORAL BUSHINGS WERE CRACKED. A NEW GMR'S DISTAL FEMUR WAS IMPLANTED ALONG WITH NEW TIBIAL POLY, BUSHINGS, BEARING, AXLE AND BUMPER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME TO THE SURGEON IN (B)(6) 2014 WITH A PATELLA FRACTURE. HE WAS SCHEDULED FOR A PATELLECTOMY. THE SURGEON'S PLAN DURING SURGERY WAS TO CHANGE THE TIBIAL POLY BEARINGS, BUSHINGS AND BUMPER. DURING SURGERY IT WAS NOTED THAT THE MEDIAL SIDE OF THE TIBIAL BEARING HAD BROKEN OFF AND THE FEMORAL BUSHINGS WERE CRACKED. A NEW GMRS DISTAL FEMUR WAS IMPLANTED ALONG WITH NEW TIBIAL POLY, BUSHINGS, BEARING, AXLE AND BUMPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571575 REVERSE CROSSOVER IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH R1AYB

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| O| R