BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3830922 · Received May 23, 2014

    Report

    Report Number
    0002249697-2014-01948
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN UNI FEMORAL COMPONENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING FEMORAL LOOSENING INVOLVING A UNKNOWN UNI FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS CONFIRMED. -MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS AND X-RAYS BY A CLINICAL CONSULTANT CONCLUDED: ¿NO PRIMARY OR REVISION OPERATIVE REPORTS, NO POST-OPERATIVE REVISION X-RAYS, AND NO EXAMINATION OF THE EXPLANTED COMPONENTS ARE AVAILABLE. BASED UPON THE DOCUMENTATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REVISION SURGERY FIVE-AND-A-HALF YEARS STATUS-POST UNICOMPARTMENTAL KNEE ARTHROPLASTY IMPLANTATION IN THIS CASE.¿ CONCLUSIONS: ALTHOUGH THE EVENT WAS CONFIRMED, THE ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. PER CLINICAL CONSULTANT BASED ON THE DOCUMENTATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE THE CAUSE FOR THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A UNI KNEE REVISION DUE TO FEMORAL LOOSENING AND PAIN. CONVERTED TO A TOTAL KNEE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A UNI KNEE REVISION DUE TO FEMORAL LOOSENING AND PAIN. CONVERTED TO A TOTAL KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307481 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention