BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERIDIAN TMZF HIP STEM #3/13MM

    MDR report key: 3852200 · Received June 5, 2014

    Report

    Report Number
    0002249697-2014-02138
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K972228
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LOOSENING INVOLVING A MERIDIAN STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT INFORMATION WAS RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS RECEIVED. FURTHER INFORMATION SUCH AS RETURN OF DEVICE, POST REVISION X-RAYS, PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A MERIDIAN HIP STEM WAS LOOSE IN A PATIENT. THE STEM WAS PULLED ALONG WITH THE POLY LINER. AN MDM LINER WAS PUT IN ALONG WITH A SECUR-FIT MAX STEM.

    Description of Event or Problem · 1

    A MERIDIAN HIP STEM WAS LOOSE IN A PATIENT. THE STEM WAS PULLED ALONG WITH THE POLY LINER. AN MDM LINER WAS PUT IN ALONG WITH A SECUR-FIT MAX STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329236 MERIDIAN TMZF HIP STEM #3/13MM IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH 37587101

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R