BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT SER. II CUP INS. 0 DEG.

    MDR report key: 4221770 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04158
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    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

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING INSTABILITY INVOLVING AN OMNIFIT LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS NOT PERFORMED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. 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.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIP WAS UNSTABLE. DOCTOR REVISED LEFT HIP DUE TO CONSTRAINED LINER. DOCTOR SAID REVISION NOT RELATED TO IMPLANTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIP WAS UNSTABLE. DOCTOR REVISED LEFT HIP DUE TO CONSTRAINED LINER. DOCTOR SAID REVISION NOT RELATED TO IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703797 OMNIFIT SER. II CUP INS. 0 DEG. IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH 1RAHE

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention