BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY HV CEMENT

    MDR report key: 2896545 · Received January 4, 2013

    Report

    Report Number
    1818910-2013-10247
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    DEPUY CMW ¿ REG. # 9610921
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. C. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS SUDDEN KNEE PAIN AND LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/IMPLANT INTERFACE. DEPUY CEMENT WAS USED AT THE TIME OF ORIGINAL IMPLANTATION. IT WAS REPORTED THAT THE SURGEON BELIEVED THAT HE HAD PUNCHED THE TIBIA FOR A 2.5 TRAY AND DECIDED TO RECUT THE TIBIA EITHER VARUS OR VALGUS. HE THEN REPUNCHED. HE DID NOT CEMENT THE KEEL HOLE, AND HE BELIEVES THIS ALLOWED THE TRAY TO TOGGLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5205 UNKNOWN DEPUY HV CEMENT BONE CEMENT LOD DEPUY CMW ¿ REG. # 9610921 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention