BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT SER. II CUP INS. 0 DEG.

    MDR report key: 4093889 · Received September 16, 2014

    Report

    Report Number
    0002249697-2014-03509
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K943054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED 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

    AN EVENT REGARDING PERIPROSTEHTIC FRACTURE INVOLVING AN UNKNOWN STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS NOT PERFORMED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, PROGRESS NOTES, X-RAYS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A REVISION OF LEFT HIP DUE TO POLY WEAR. DOCTOR REVISED THE POLY AND HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A REVISION OF LEFT HIP DUE TO POLY WEAR. DOCTOR REVISED THE POLY AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571625 OMNIFIT SER. II CUP INS. 0 DEG. IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH 1PVHN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention