BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY PINNACLE METAL LINER

    MDR report key: 2973737 · Received February 22, 2013

    Report

    Report Number
    1818910-2013-12726
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    February 25, 2013
    Report Date
    October 7, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    PK062426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS RECEIVED. IT IS ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, LACK OF MOBILITY, METALLOSIS, AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78546 UNKNOWN DEPUY PINNACLE METAL LINER METAL LINER KWA DEPUY ORTHOPAEDICS INC US 3050380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention AML LG STATURE 13.5MM.| ASPHERE M SPEC 12/14 40 -2.| PINNACLE 100 ACET CUP 58MM.| ZIMMER PIN STEINMAN.