BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRSVN AP TIB LM/RL SZ4 7MM

    MDR report key: 2945761 · Received February 6, 2013

    Report

    Report Number
    1818910-2013-11968
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 21, 2013
    Report Date
    February 4, 2013
    Manufacturer
    DEPUY SYNTHES
    Product Code
    HRY
    PMA / PMN Number
    PK010810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. REVIEW OF PROVIDED PATIENT X-RAYS FINDS THE SIZING LOOKS APPROPRIATE AND NO EVIDENCE OF LOOSENING IS FOUND. THE FEMORAL COMPONENT IS SLIGHTLY MEDIAL ON THE AP AND SUNRISE VIEWS. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    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.

    Description of Event or Problem · 1

    THIS PATIENT HAD DEVELOPED MEDIAL KNEE PAIN IN THE YEAR PRIOR TO REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50481 PRSVN AP TIB LM/RL SZ4 7MM TIBIAL KNEE COMPONENT HRY DEPUY SYNTHES B4EBL4

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention