BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR +4 10D 36IDX54OD

    MDR report key: 3781541 · Received April 30, 2014

    Report

    Report Number
    1818910-2014-17779
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.-1818910
    Product Code
    LPH
    PMA / PMN Number
    PK033273
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PATIENT WAS REVISED TO ADDRESS CUP MALPOSITIONING AND POLY WEAR.EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. THE INITIAL REPORTING INDICATES THE PATIENT WAS REVISED TO ADDRESS A VERTICAL CUP AND SUBSEQUENT ECCENTRIC POLY-WEAR. PATIENT X-RAYS WERE NOT PROVIDED AND POSITIONING CANNOT BE COMMENTED UPON. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS CUP MALPOSITIONING AND POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260410 PINN MAR +4 10D 36IDX54OD HIP ACETABULAR INSERT/LINER LPH DEPUY ORTHOPAEDICS, INC.-1818910 W25AG1

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention