BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT SER. II INSERT 20 DEG.

    MDR report key: 3430259 · Received October 25, 2013

    Report

    Report Number
    0002249697-2013-03457
    Event Type
    Injury
    Date Received
    October 25, 2013
    Date of Event
    October 1, 2013
    Report Date
    October 1, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K943054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE OTHER DEVICE LISTED IN THIS REPORT IS A C-TAPER COCR LFIT HEAD 32MM/+10, CAT # 06-3210, LOT 3M1MHE. IT CANNOT BE DETERMINED WHICH, IF EITHER OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED.

    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. A REVIEW OF THE PROVIDED X-RAY BY A CLINICIAN CONSULTANT INDICATED THAT THERE IS NOT ENOUGH INFORMATION ON FILE TO FURTHER DETAIL THIS, SO SEVERAL ASPECTS MAY REMAIN SOMEWHAT SPECULATIVE ALTHOUGH THERE SHOULD BE NO DOUBT AS TO THE ROLE OF PROCEDURE-RELATED FACTORS IN THE FAILURE SCENARIO AND THE POTENTIAL SECONDARY ROLE OF PATIENT-RELATED FACTORS REGARDING MORBID OBESITY OF THE PATIENT AGGRAVATING THE OVERLOAD CONDITION. NO EVIDENCE FOR DEVICE-RELATED FACTORS PLAYING A ROLE IN THIS CASE.¿ THE EVENT COULD NOT BE CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, PROGRESS NOTES, AND PRE-OPERATIVE X-RAYS ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LINER AND HEAD WERE EXCHANGED DUE TO PATIENT PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LINER AND HEAD WERE EXCHANGED DUE TO PATIENT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548788 OMNIFIT SER. II INSERT 20 DEG. IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH 15KDT

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R