BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLEX HV US 1 PACK

    MDR report key: 8224053 · Received January 7, 2019

    Report

    Report Number
    0002249697-2019-00062
    Event Type
    Injury
    Date Received
    January 7, 2019
    Date of Event
    February 19, 2018
    Report Date
    January 7, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    UDI-DI
    04260056885747
    PMA / PMN Number
    K123225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. STRYKER ORTHOPAEDICS IS A DISTRIBUTOR OF THIS DEVICE, WHICH IS MANUFACTURED BY AAP. THE MANUFACTURER HAS RESPONSIBILITY FOR REGULATORY DECISIONS AND MDR/MDV REPORTING. SUPPLIER HAS BEEN NOTIFIED. SERIOUS INJURY REPORTS FOR HV PRODUCTS ARE ALSO FILED TO THE FDA VIA STRYKER PERSONNEL. NOT RETURNED.

    Description of Event or Problem · 1

    IT'S ALLEGED BY THE ATTORNEY, THROUGH THE FILING OF A LAWSUIT, THAT ON (B)(6) 2015 SIMPLEX HV BONE CEMENT WAS USED ON THE PLAINTIFF DURING A RIGHT TKA. ITS FURTHER ALLEGED THAT THE PLAINTIFFS RIGHT KNEE HAD TO BE REVISED ON (B)(6) 2018 DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16415 SIMPLEX HV US 1 PACK BONE CEMENT LOD STRYKER ORTHOPAEDICS-MAHWAH 521AAB54DW 04260056885747

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R