BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 2960708 · Received February 14, 2013

    Report

    Report Number
    1818910-2013-03870
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    October 3, 2011
    Report Date
    September 18, 2013
    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
    US
    Reporter Occupation
    PATIENT

    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. 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

    DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE PATIENT WAS BI-LATERAL. THE PATIENT WAS REVISED ON THE RIGHT HIP DUE TO PAINFUL RETAINED HARDWARE WITH METAL ON METAL RELATED CYSTIC LESION, HOWEVER, THE DEPUY DEVICES WERE NOT REMOVED. AN UNKNOWN CLAMP AND CABLE WAS REMOVED DURING REVISION.

    Description of Event or Problem · 1

    UPDATE: (B)(4) /2013 -LEGAL CLAIM RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM DISCOMFORT. THE DOI WAS PROVIDED AND UPDATED ON THE COMPLAINT. THERE IS NO NEW INFORMATION THAT WOULD AFFECT THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65016 ASR ACETABULAR CUPS 56 ACETABULAR CUP KWA DEPUY INTERNATIONAL 2568309

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention