BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIT HA PSL CUP/CLUSTR SHELL 48MM

    MDR report key: 4210959 · Received October 29, 2014

    Report

    Report Number
    0002249697-2014-04052
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K942900
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. PATIENT KEPT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING WEAR INVOLVING AN OMNIFIT LINER WAS REPORTED. CONCLUSION: NO ALLEGATION OF FAILURE WAS MADE AGAINST THE DEVICE. BASED ON THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THE PRODUCT REPORTED IN THIS INVESTIGATION CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    PATIENTS ACETABULUM WAS REVISED FOR POLY WEAR. CUP WAS EXPLANTED AND REPLACED WITH TRITANIUM PRIMARY SHELL AND MDM LINER.

    Description of Event or Problem · 1

    PATIENTS ACETABULUM WAS REVISED FOR POLY WEAR. CUP WAS EXPLANTED AND REPLACED WITH TRITANIUM PRIMARY SHELL AND MDM LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692311 SECUR-FIT HA PSL CUP/CLUSTR SHELL 48MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 18375904

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention