BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 2213207 · Received August 12, 2011

    Report

    Report Number
    1818910-2011-15041
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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. EPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    CORRECTED: BRAND NAME, COMMON DEVICE NAME/DEVICE PRODUCT CODE, CATALOG #/LOT #, DATE RECEIVED BY MFR, 510K, MANUFACTURE DATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PT WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT. LITIGATION PAPERS ALLEGE THE PATIENT WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT. DOI: (B)(6) 2007 - DOR: NONE REPORTED (RIGHT HIP). PATIENT IS A RESIDENT OF (B)(6). UPDATE: 1/18/2012 PLAINTIFF FACT SHEET RECEIVED WITH PART/LOT INFORMATION. NO NEW INFORMATION WAS RECEIVED THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE 15 OCT 2014 - DER RCVD. UPDATED DOR, ADDED PAIN AND FLUID AS REASONS FOR REVISION. ADDED SALES REP INFORMATION. LOT NUMBER SUPPLIED FOR CUP AS NOT COMING UP ON OUR SYSTEM SO REPORTED AS UNKNOWN LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 56 HIP ACETABULAR CUP KWA DEPUY ORTHOPAEDICS, INC. NA Y57F71

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention