BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACETABULAR CUP UHMWPE

    MDR report key: 3984180 · Received August 6, 2014

    Report

    Report Number
    0002249697-2014-03017
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LOOSENING INVOLVING AN UNKNOWN SHELL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR IDENTIFICATION OR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: NO PATIENT MEDICAL RECORDS WERE AVAILABLE FOR REVIEW. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LOOSENING INVOLVING AN OMNIFIT SHELL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: THE DEVICE WAS RECEIVED FOR EVALUATION. A SIGNIFICANT AMOUNT OF BONE CEMENT WAS FOUND ON MUCH OF THE BACK SIDE OF THE POLY CUP. THE POLY CUP WAS DAMAGED IN ONE LOCATION OF THE OUTER RIM, LIKELY A RESULT OF EXPLANTATION DAMAGE. THE CUP WAS YELLOWISH IN COLOR AND WEAR OF THE ARTICULATING SURFACE WAS OBSERVED, CONSISTENT LONG TERM SERVICE IN VIVO. CONCLUSIONS: THE EVENT OF LOOSENING COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS INSUFFICIENT INFORMATION WAS RECEIVED BY (B)(4). IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN CUP. WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A LEFT HIP REVISION DUE TO LOOSENING. DOCTOR REMOVED STEM, CUP AND HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A LEFT HIP REVISION DUE TO LOOSENING. DOCTOR REMOVED STEM, CUP AND HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A LEFT HIP REVISION DUE TO LOOSENING. DOCTOR REMOVED STEM, CUP AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460807 ACETABULAR CUP UHMWPE PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER KWZ STRYKER ORTHOPAEDICS-MAHWAH AHFA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention