BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR 300 SPIKED CUP SIZE 52

    MDR report key: 2231798 · Received September 1, 2011

    Report

    Report Number
    1818910-2011-17016
    Event Type
    Injury
    Date Received
    September 1, 2011
    Report Date
    August 3, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K073413
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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. (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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HER LEFT SIDE ON (B)(6) 2009. AFTER THE SURGERY, PATIENT EXPERIENCED SEVERE PAIN AND DISCOMFORT, EXPRESSED SYMPTOMS INDICATING A LOOSE IMPLANT, AND WILL ULTIMATELY UNDERGO REVISION SURGERY. SHE HAS ALSO SUFFERED LOSS OF MUSCLE MASS, LOSS OF SLEEP, HAS DIFFICULTY MAINTAINING HER BALANCE, AND WALKS WITH A LIMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR 300 SPIKED CUP SIZE 52 ACETABULAR CUP KWA DEPUY INTERNATIONAL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention