BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V40 COCR LFIT HEAD 36MM/+5

    MDR report key: 2221275 · Received August 17, 2011

    Report

    Report Number
    2249697-2011-01196
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 8, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K022077
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THE SALES REP, ON BEHALF OF THE CUSTOMER, THAT A REVISION TOOK PLACE AFTER 18 MONTHS OF THE INITIAL IMPLANTATION DUE TO MICROMOTION BETWEEN THE HEAD AND THE STEM. HE ADDED THAT DURING THE REVISION, THE SURGEON IMPLANTED AN ACOLADE STEM AND A CERAMIC HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V40 COCR LFIT HEAD 36MM/+5 IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA NXNMEE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R