BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX30MM

    MDR report key: 2924530 · Received January 22, 2013

    Report

    Report Number
    1818910-2013-11274
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NDJ
    PMA / PMN Number
    PK983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. REVIEW OF PROVIDED PATIENT X-RAYS CONFIRMS THE REPORTED MALPOSITIONING AND SUBSEQUENT DISLOCATION. COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION CAN DRAW NO FURTHER CONCLUSIONS WITH THE INFORMATION PROVIDED. PRODUCT PROBLEM HAS NOT BEEN IDENTIFIED. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS MALPOSITIONING AND LOOSENING OF THE CUP, WHICH WAS CAUSING DISLOCATION. IT WAS NOTED THAT THERE WAS NO POROUS INGROWTH, ONLY FIBROUS INGROWTH. POLY WEAR WAS ALSO REPORTED ON THE LINER RIM AT THE POINT OF DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29042 PINN CAN BONE SCREW 6.5MMX30MM BONE SCREW NDJ DEPUY ORTHOPAEDICS, INC. X2JJK1000

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention