BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLEX HV WITH GENTAMICIN US 1 PACK

    MDR report key: 6514001 · Received April 22, 2017

    Report

    Report Number
    0002249697-2017-01340
    Event Type
    Injury
    Date Received
    April 22, 2017
    Date of Event
    August 31, 2016
    Report Date
    July 21, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    PMA / PMN Number
    K123081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LOOSENING INVOLVING SIMPLEX HV CEMENT WAS REPORTED. THE EVENT RELATES TO PRODUCT SUPPLIED BY AN OEM. STRYKER ORTHOPAEDICS IS A DISTRIBUTOR OF THIS DEVICE, WHICH IS MANUFACTURED BY AAP. THE MANUFACTURER IS RESPONSIBLE FOR REGULATORY DECISIONS UNDER MDR/MDV AND SUBMITTING ANY REQUIRED MDR/MDV REPORTS. SUPPLIER HAS BEEN NOTIFIED. SERIOUS INJURY REPORTS FOR HV PRODUCTS ARE ALSO FILED TO THE FDA VIA STRYKER PERSONNEL HOWEVER THE INVESTIGATION AND RESULTS ARE PROCESSED BY AAP.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT ALLEGEDLY THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015 WHERE STRYKER SIMPLEX CEMENT WITH GENTAMICIN WAS USED. IT IS FURTHER ALLEGED THAT THE PATIENT HAD TO BE REVISED ON (B)(6) 2016.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT ALLEGEDLY THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015 WHERE STRYKER SIMPLEX CEMENT WITH GENTAMICIN WAS USED. IT IS FURTHER ALLEGED THAT THE PATIENT HAD TO BE REVISED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296193 SIMPLEX HV WITH GENTAMICIN US 1 PACK BONE CEMENT LOD STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R