BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS R BONE CEMENT

    MDR report key: 3003885 · Received March 12, 2013

    Report

    Report Number
    1526350-2013-00115
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    March 1, 2012
    Report Date
    February 10, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    LOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR. A F/U MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT STATED CHRONIC NERVE PAIN AFTER LEFT KNEE IMPLANT. SURGEON FOUND CRUMBLED CEMENT WHEN IMPLANT WAS REMOVED ON A REVISION SURGERY ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103604 PALACOS R BONE CEMENT PALACOS R BONE CEMENT LOD ZIMMER SURGICAL NA 69484237

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention CROSS-LINKED CURVED INSERT: REF 1581-15-110,| LOT 2940739| REF 1581-80-000, LOT 2357776| SIGMA FEMORAL CRUCIATE RETAINING CEMENTED| OVAL DOME PATELLA 3-PEG: REF 96-0103, LOT 3154476| SIZE 6 LEFT: REF 86-0005, LOT EF8D44| P.F.C. SIGMA MODULAR TIBIAL TRAY CEMENTED-COCR: