BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLEX P FULL DOSE 1 PACK

    MDR report key: 3002502 · Received March 13, 2013

    Report

    Report Number
    0002249697-2013-00970
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 21, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    PMA / PMN Number
    K062553
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING IMPLANT LOOSENING INVOLVING SIMPLEX BONE CEMENT WAS REPORTED. DEVICE HISTORY REVIEW INDICATES THERE WERE NO REPORTED DISCREPANCIES FOR THE REFERENCED LOT. COMPLAINT HISTORY REVIEW INDICATES THERE WERE NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION SUCH AS PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY, FOLLOW-UP NOTES, AND IMPLANT IDENTIFICATION INFORMATION ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. THE EVENT WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD REVISION SURGERY OF A LEFT TOTAL KNEE ARTHROPLASTY. THERE WAS EITHER DISASSOCIATION BETWEEN THE CEMENT AND BASEPLATE OR CEMENT FAILURE WITH BASEPLATE, NECESSITATING RE-OPERATION TO REPLACE BOTH. ORIGINAL DATE OF SURGERY WAS (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD REVISION SURGERY OF A LEFT TOTAL KNEE ARTHROPLASTY. THERE WAS EITHER DISASSOCIATION BETWEEN THE CEMENT AND BASEPLATE OR CEMENT FAILURE WITH BASEPLATE, NECESSITATING RE-OPERATION TO REPLACE BOTH. ORIGINAL DATE OF SURGERY WAS (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105826 SIMPLEX P FULL DOSE 1 PACK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH RFQ132

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention