BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM

    MDR report key: 1714369 · Received June 3, 2010

    Report

    Report Number
    2249697-2010-00606
    Event Type
    Other
    Date Received
    June 3, 2010
    Date of Event
    September 7, 2009
    Report Date
    May 14, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K081171
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY STRYKER ORTHOPAEDICS' CLINICAL DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ADDITIONAL FOLLOW-UP INFORMATION MAY BE OBTAINED BY THE CLINICAL DEPARTMENT AS IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    I CONTACTED STUDY COORDINATOR FOR DR BY PHONE ON (B)(6) 2010 IN RESPONSE TO AN E-MAIL REQUEST FOR ASSISTANCE WITH DATA CLARIFICATION REQUESTS (DCRS) AS DR PARTICIPATING IN THE TRIDENT TRITANIUM ACETABULAR REVISION SHELL STUDY. IN THE PHONE CONVERSATION INDICATED THAT STUDY SUBJECT (B)(4) HAD EXPERIENCED A FALL APPROXIMATELY TWO WEEKS POST OPERATIVELY WHICH RESULTED IN A FRACTURED WRIST. INDICATED THE PT CLAIMED THAT THE FALL WAS A RESULT OF THE HIP. I WAS ABLE TO DETERMINE THAT THE SUBJECT IS NOW MORE THAN 1-YEAR POST-OPERATIVE AND THE DEVICE IS STILL IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA MHDP5H

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention