BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V40 COCR LFIT HEAD 40MM/+12

    MDR report key: 3010131 · Received March 19, 2013

    Report

    Report Number
    0002249697-2013-01016
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K061434
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. A REVIEW OF THE PROVIDED X-RAY BY A CLINICAL CONSULTANT DETERMINED THAT THERE WAS NOT ENOUGH INFORMATION FOR A DETAILED REVIEW AS THERE IS NO CONFIRMATION OF PELVIC FRACTURE. THE EVENT WAS NOT CONFIRMED. COMPLAINT HISTORY REVIEW: THE SUPER AND TRACKWISE COMPLAINT DATABASES SHOWS THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION SUCH AS X-RAYS, OPERATIVE REPORTS, AND CLINICAL HISTORY ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DOCTOR SENT DEVICE TO PATHOLOGY AND IT WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    BIOMET CUP AND LINER WAS COMBINED WITH STRYKER HEAD IN THE REVISION OF THE PRIMARY. THIS CONSTRUCT INCLUDING THE STRYKER HEAD WAS REVISED DUE TO PELVIC FRACTURE DUE TO UNKNOWN TRAUMA. NO MEDICAL RECORDS OR FORMAL X-RAYS WILL BE MADE AVAILABLE.

    Description of Event or Problem · 1

    BIOMET CUP AND LINER WAS COMBINED WITH STRYKER HEAD IN THE REVISION OF THE PRIMARY. THIS CONSTRUCT INCLUDING THE STRYKER HEAD WAS REVISED DUE TO PELVIC FRACTURE DUE TO UNKNOWN TRAUMA. NO MEDICAL RECORDS OR FORMAL X-RAYS WILL BE MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113663 V40 COCR LFIT HEAD 40MM/+12 IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH JVHMME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention