BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR CUP

    MDR report key: 2211785 · Received August 10, 2011

    Report

    Report Number
    1818910-2011-14517
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    June 22, 2011
    Report Date
    July 11, 2011
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: LITIGATION PAPERS ALLEGE: PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP ON HER RIGHT SIDE ON OR ABOUT (B)(6) 2009. AFTER HER SURGERY, PATIENT EXPERIENCED PAIN AND DISCOMFORT IN HER RIGHT HIP, METALLOSIS EXPOSURE, AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT. PATIENT HAD THE ASR HIP EXPLANTED ON (B)(6) 2011. DOI: (B)(6) 2009 - DOR: (B)(6) 2011 (RIGHT SIDE). PATIENT IS A RESIDENT OF (B)(6). THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: PT WAS IMPLANTED WITH A DEPUY ASR HIP ON HER RIGHT SIDE ON OR ABOUT (B)(6) 2009. AFTER HER SURGERY, PT EXPERIENCED PAIN AND DISCOMFORT IN HER RIGHT HIP, METALLOSIS EXPOSURE, AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT. PT HAD THE ASR HIP EXPLANTED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR CUP TOTAL HIP REPLACEMENT KWA DEPUY INTL., LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention