BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCODLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZ

    MDR report key: 1081732 · Received July 18, 2008

    Report

    Report Number
    9616680-2008-00210
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    March 17, 2008
    Report Date
    June 18, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THIS REPORT WAS REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT STATED THAT SHE HAS BEEN EXPERIENCING PAIN EVER SINCE SHE HAD A RIGHT HIP IMPLANT IN (B) (6) 2008. SHE EXPLAINED THAT SHE HAS BEEN TO HER DOCTOR AND IS CURRENTLY TAKING MORPHINE FOR THE PAIN AND IT IS NOT HELPING AT ALL BECAUSE SHE HAS CONSTANT PAIN. SHE ALSO ADDED THAT BECAUSE OF THE PAIN, SHE IS HOME BOUND AND IS NOT THE OUTDOOR ACTIVE WOMAN SHE USED TO BE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCODLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZ IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 24885205

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other