BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT SER. II INSERT-10 DEG.

    MDR report key: 3844871 · Received June 3, 2014

    Report

    Report Number
    0002249697-2014-02034
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K943054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING WORN INSERT AND DISLOCATION INVOLVING A OMNIFIT SER. II INSERT-10 DEG. WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: INDICATED ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NO MEDICAL RECORDS AND/OR DEVICE WERE RECEIVED. FURTHER INFORMATION SUCH AS PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Description of Event or Problem · 1

    REMOVAL OF WORN AND DISLOCATING ACETABULAR COMPONENT. FEMORAL HEAD WAS ALSO REMOVED. ADDITIONAL INFORMATION RECEIVED FROM SALES REP ON (B)(6), 2014: ACETABULAR INSERT WAS WORN. EDGE OF ACETABULAR SHELL WAS WORN FROM MULTIPLE DISLOCATIONS. HEAD ALSO WAS WORN FROM MULTIPLE DISLOCATIONS.

    Description of Event or Problem · 1

    REMOVAL OF WORN AND DISLOCATING ACETABULAR COMPONENT. FEMORAL HEAD WAS ALSO REMOVED. ADDITIONAL INFORMATION RECEIVED FROM SALES REP ON MAY 21, 2014: ACETABULAR INSERT WAS WORN. EDGE OF ACETABULAR SHELL WAS WORN FROM MULTIPLE DISLOCATIONS. HEAD ALSO WAS WORN FROM MULTIPLE DISLOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324922 OMNIFIT SER. II INSERT-10 DEG. IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH AXAC

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention