BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 3230684 · Received July 16, 2013

    Report

    Report Number
    1818910-2013-21386
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    July 11, 2013
    Report Date
    August 2, 2013
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATON CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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.

    Description of Event or Problem · 1

    PATIENT UNDERWENT REVISION PROCEDURE OF RIGHT HIP DUE TO PAIN.

    Description of Event or Problem · 1

    UPDATE (B)(4) 2013: LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES ELEVATED METAL ION LEVELS. DOI PROVIDED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION.

    Description of Event or Problem · 1

    UPDATE (B)(4) 2013 - ASR SUPPLEMENTAL INFO FORM WAS RECEIVED, WHICH IDENTIFIED DOB INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. COMPLAINT WAS UPDATED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330056 ASR ACETABULAR CUPS 56 ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention