BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT SER. II INSERT-10 DEG.

    MDR report key: 4123350 · Received September 26, 2014

    Report

    Report Number
    0002249697-2014-03664
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    April 11, 2014
    Report Date
    September 3, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K943054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING WEAR INVOLVING AN OMNIFIT SERIES II LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO MEDICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED AT THE (B)(6). THE THA WITH OMNIFIT PLUS CUP AND OMNIFIT SERIES 2 INSERT WAS DONE. AFTER THIS, REVISION SURGERY OF THE OMNIFIT SERIES 2 INSERT AND HEAD WERE DONE BECAUSE THE LINER WAS WORN.

    Description of Event or Problem · 1

    IT WAS REPORTED AT (B)(6) ASSOCIATION OF ORTHOPAEDIC SURGERY & TRAUMATOLOGY. THE THA WITH OMNIFIT PLUS CUP AND OMNIFIT SERIES 2 INSERT WAS DONE. AFTER THIS, REVISION SURGERY OF THE OMNIFIT SERIES 2 INSERT AND HEAD WERE DONE BECAUSE THE LINER WAS WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602517 OMNIFIT SER. II INSERT-10 DEG. IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention