BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT M/S PSL SHELL 56MM

    MDR report key: 2950940 · Received February 8, 2013

    Report

    Report Number
    0002249697-2013-00603
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 22, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K903636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A REVISION DUE TO PAIN INVOLVING AN OMNIFIT PSL SHELL WAS REPORTED. DEVICE EVALUATION COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR IDENTIFICATION OR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO MEDICAL INFORMATION WAS PROVIDED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED PAIN MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4): NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    ACETABULAR REVISION DUE TO PAIN.

    Description of Event or Problem · 1

    ACETABULAR REVISION DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54276 OMNIFIT M/S PSL SHELL 56MM IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention