BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT SER. II INSERT-10 DEG.

    MDR report key: 2925469 · Received January 22, 2013

    Report

    Report Number
    0002249697-2013-00155
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K943054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED DUE TO THE LIMITED INFORMATION PROVIDED. THE REASON FOR THE REVISION SURGERY WAS NOT PROVIDED. THE EXPLANTED COMPONENTS, PATIENT DETAILS, MEDICAL RECORDS OR X-RAYS WOULD BE NECESSARY TO DETERMINE A ROOT CAUSE.

    Description of Event or Problem · 1

    SURGEON REQUESTED CONSTRAINED LINERS FOR A INSERT AND HEAD EXCHANGE.

    Description of Event or Problem · 1

    SURGEON REQUESTED CONSTRAINED LINERS FOR A INSERT AND HEAD EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29305 OMNIFIT SER. II INSERT-10 DEG. IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH 1PCFJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R