BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE PLUS TMZF HIP STEM #4

    MDR report key: 3840478 · Received May 30, 2014

    Report

    Report Number
    0002249697-2014-01970
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    January 18, 2010
    Report Date
    May 5, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K121308
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN STRYKER RIGHT HIP. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION OR EVIDENCE TO SUGGEST THE STEM CONTRIBUTED TO THE EVENT. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PATIENT'S SURGERY, SHE NOTICED THERE WAS A LEG LENGTH DISCREPANCY WHEN SHE WALKS, SHE FEELS LIKE SHE IS OFF BALANCE AND IS IN CONSTANT PAIN. PATIENT CLAIMS SHE FELL SIX TIMES AFTER HER REVISION SURGERY. RIGHT HIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PATIENT'S SURGERY SHE NOTICED THERE WAS A LEG LENGTH DISCREPANCY WHEN SHE WALKS, SHE FEELS LIKE SHE IS OFF BALANCE AND IS IN CONSTANT PAIN. PATIENT CLAIMS SHE FELL SIX TIMES AFTER HER REVISION SURGERY. RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319324 ACCOLADE PLUS TMZF HIP STEM #4 IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH 31895606

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention