BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR +4 10D 46ODX28ID

    MDR report key: 2071474 · Received April 15, 2011

    Report

    Report Number
    1818910-2011-05636
    Event Type
    Injury
    Date Received
    April 15, 2011
    Report Date
    March 17, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K033273
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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

    EXAMINATION OF THE RETURNED PRODUCTS CONFIRMED THE REPORTED EVENT. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT: HOWEVER EVIDENCE SUGGESTS RIM LOADING AND THE LINER WAS NOT PROPERLY SEATED CAN BE ATTRIBUTED TO THE REPORTED EVENT. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. REVIEW OF THE ATTACHED DHR FOR 121928146 PINN MAR LOT CK4A410 DID NOT REVEAL ANY ANOMALIES. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    MARATHON INLAY LOOSENING AFTER ABOUT 2 YEARS OF IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN MAR +4 10D 46ODX28ID 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA CK4A410

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention