BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11/13 S-ROM 40MM M SPEC+0

    MDR report key: 3252762 · Received July 29, 2013

    Report

    Report Number
    1818910-2013-22371
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    April 19, 2011
    Report Date
    July 16, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    PK060031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. 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 ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED. DEPUY HAS RECEIVED INFORMATION STATING THAT THE DEPUY (PRODUCT) WAS USED IN CONJUNCTION WITH A COMPETITOR (PRODUCT). MANUFACTURER: STRYKER. PRODUCT: UNKNOWN PRODUCT.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352889 11/13 S-ROM 40MM M SPEC+0 HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 2639840
    352942 11/13 S-ROM 40MM M SPEC+0 HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US 2639840

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention