BEUDAMED
    FDA Adverse Event Death Summary report: N

    UHR BIPOLAR 26X43MM

    MDR report key: 7868355 · Received September 12, 2018

    Report

    Report Number
    0002249697-2018-02840
    Event Type
    Death
    Date Received
    September 12, 2018
    Date of Event
    August 16, 2014
    Report Date
    September 12, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    UDI-DI
    07613327016864
    PMA / PMN Number
    K173499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO THE ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. NOT AVAILABLE.

    Description of Event or Problem · 1

    ITS ALLEGED BY THE PATIENT'S SON, THROUGH THE FILLING OF A LEGAL CLAIM, THAT THE PATIENT UNDERWENT A RIGHT HIP HEMIARTHROPLASTY ON (B)(6) 2014. IT IS FURTHER ALLEGED THAT AFTER IMPLANTATION THE PATIENT EXPERIENCED PAIN, INFECTION, THYROID PROBLEMS, LEG LENGTH DISCREPANCY, WEIGHT GAIN, SKIN RASHES AND FATIGUE. PATIENT SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711493 UHR BIPOLAR 26X43MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI STRYKER ORTHOPAEDICS-MAHWAH MLE005 07613327016864

    Patients

    Seq Age Sex Outcome Treatment
    1 Death