BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUP 50

    MDR report key: 3073462 · Received April 23, 2013

    Report

    Report Number
    1818910-2013-02874
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    January 5, 2015
    Report Date
    January 5, 2015
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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. (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

    UPDATE: (B)(4) 2013- PPD RECEIVED. PART/LOT INFORMATION HAS BEEN UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY CONSIDERS THIS COMPLAINT CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE PATIENT SUFFERED PAIN, STIFFNESS, DISCOMFORT, WEAKNESS, DECREASED MOBILITY AND METAL TOXICITY DUE TO THE IMPLANTED ASR HIP.

    Description of Event or Problem · 1

    UPDATE 5 JAN 2015 - DER RCVD. UPDATED DOR, SURGEON AND SALES REP INFO, PATIENT ACTIVITY LEVEL AND DOB. UPDATED THE CUP AND HEAD TO REFLECT THE METAL IONS AND ADDED THE EXPIRY DATE, COMMON AND BRAND NAMES. ADDED STEM AND SLEEVE PRODUCTS. ALSO ADDED 510K NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174561 ASR ACETABULAR CUP 50 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2899057

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other| R