BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ACCOLADE II HIP SEM

    MDR report key: 9165814 · Received October 8, 2019

    Report

    Report Number
    0002249697-2019-03447
    Event Type
    Injury
    Date Received
    October 8, 2019
    Date of Event
    February 24, 2016
    Report Date
    October 8, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2015 AND WAS REVISED ON (B)(6) 2016. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963309 UNKNOWN ACCOLADE II HIP SEM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R