BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM

    MDR report key: 3781441 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01558
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    December 17, 2012
    Report Date
    April 7, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K081171
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING SHELL LOOSENING INVOLVING A PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: REVIEW BY A CLINICIAN INDICATES THAT THERE IS NO EVIDENCE TO SUGGEST THAT FAULTY DESIGN, MANUFACTURING, OR MATERIAL OF ANY STRYKER PRODUCTS ARE RESPONSIBLE FOR THE CLINICAL SITUATION DESCRIBED IN THIS PATIENT¿S HIPS. DEVICE HISTORY REVIEW: INDICATED THAT THE SPECIFIED LOT WAS ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: INDICATED THAT THERE HAVE NOT BEEN ANY OTHER EVENTS FOR THE SPECIFIED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NOT ENOUGH INFORMATION WAS PROVIDED. IN ORDER TO COMPLETE A FULL INVESTIGATION, ITEMS SUCH AS PATIENT HISTORY ARE NEEDED TO DETERMINE THE ROOT CAUSE. REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICIAN DID NOT INDICATE ANY DEFECTS IN THE REPORTED DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS PAIN IN RIGHT HIP, A CAT SCAN SHOWED SCREWS ARE LOOSEN AND COMING OUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS PAIN IN RIGHT HIP, A CAT SCAN SHOWED SCREWS ARE LOOSEN AND COMING OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260165 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MLR98W

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other