BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 58

    MDR report key: 2842183 · Received November 21, 2012

    Report

    Report Number
    1818910-2012-24773
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    January 13, 2014
    Report Date
    January 13, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

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

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2014- SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED METAL ION LEVELS (CHROMIUM 6.2, COBALT 10.2). THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERED SEVERE PAIN, DISABILITY, PHYSICAL IMPAIRMENT, DISFIGUREMENT, AGGRAVATION OF A PRE-EXISTING CONDITION AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 58 TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL 2442971

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other