BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCA ACE/LOW PROFILE SHELL 52MM

    MDR report key: 3203215 · Received July 2, 2013

    Report

    Report Number
    0002249697-2013-02208
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K920831
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED THAT THERE WAS NO EVIDENCE OF THE REPORTED MAL-POSITIONED SHELL. HOWEVER, IT WAS ALSO REPORTED, THAT THERE WAS A SIGNIFICANT AMOUNT OF POLY WEAR. THEREFORE, THERE IS NO INDICATION THAT THE SHELL REPORTED IN THIS INVESTIGATION CONTRIBUTED TO THE EVENT AND HAS BE DETERMINED TO BE CONCOMITANT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION DUE TO PAIN. THE CUP WAS NOT PLACED PROPERLY AND SURGEON REVISED THE CUP, WAS PLACED VERTICALLY AND WAS COMING OUT. REVISED THE FEMORAL HEAD, ACETABULAR CUP, AND LINER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION DUE TO PAIN. THE CUP WAS NOT PLACED PROPERLY AND SURGEON REVISED THE CUP, WAS PLACED VERTICALLY AND WAS COMING OUT. REVISED THE FEMORAL HEAD, ACETABULAR CUP, AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302692 PCA ACE/LOW PROFILE SHELL 52MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH SFNYA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention