BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 48

    MDR report key: 2012665 · Received February 24, 2011

    Report

    Report Number
    1818910-2011-02922
    Event Type
    Injury
    Date Received
    February 24, 2011
    Report Date
    January 28, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: LITIGATION PAPERS ALLEGE THE PATIENT HAS SUFFERED SYMPTOMS INCLUDING BUT NOT LIMITED TO PAIN, SWELLING, AND LACK OF MOBILITY. DOI: (B)(6) 2005. **(B)(6). **UPDATE - (B)(6) 2011 - LITIGATION PAPERS ALLEGE ON OR ABOUT (B)(6) 2006, PATIENT UNDERWENT HIP REPLACEMENT SURGERY. SINCE THE SURGICAL IMPLANT, PATIENT HAS SUFFERED SYMPTOMS INCLUDING BUT NOT LIMITED TO PAIN AND LACK OF MOBILITY. IT IS FURTHER ALLEGED THAT PATIENT HAS SUFFERED SIGNIFICANT HARM, INCLUDING BUT NOT LIMITED TO PHYSICAL INJURY AND BODILY IMPAIRMENT, DEBILITATING LACK OF MOBILITY, CONSCIOUS PAIN AND SUFFERING, AND LOSS OF EARNINGS. IT IS ALSO ALLEGED PATIENT HAS TESTED POSITIVE FOR ELEVATED LEVELS OF CHROMIUM AND COBALT. IT IS ALSO ALLEGED PATIENT WILL LIKELY NEED TO UNDERGO REVISION SURGERY, PHYSICAL THERAPY AND OTHER TREATMENT. DOI: (B)(6) 2006, DOR: NO REPORTED REVISION. 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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED. SHOULD 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT HAS SUFFERED SYMPTOMS INCLUDING BUT NOT LIMITED TO PAIN, SWELLING, AND LACK OF MOBILITY. UPDATE - (B)(6) 2011 - LITIGATION PAPERS ALLEGE ON OR ABUT AUGUST 1, 2006, PATIENT UNDERWENT HIP REPLACEMENT SURGERY. SINCE THE SURGICAL IMPLANT, PATIENT HAS SUFFERED SYMPTOMS INCLUDING BUT NOT LIMITED TO PAIN AND LACK OF MOBILITY. IT IS FURTHER ALLEGED THAT PATIENT HAS SUFFERED SIGNIFICANT HARM, INCLUDING BUT NOT LIMITED TO PHYSICAL INJURY AND BODILY IMPAIRMENT, DEBILITATING LACK OF MOBILITY, CONSCIOUS PAIN AND SUFFERING, AND LOSS OF EARNINGS. IT IS ALSO ALLEGED PATIENT HAS TESTED POSITIVE FOR ELEVATED LEVELS OF CHROMIUM AND COBALT. IT IS ALSO ALLEGED PATIENT WILL LIKELY NEED TO UNDERGO REVISION SURGERY, PHYSICAL THERAPY AND OTHER TREATMENT. UPDATE: (B)(6) 2012 - THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS ACETABULAR CUP LOOSENING AND PAIN.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE, THE PT HAS SUFFERED SYMPTOMS INCLUDING BUT NOT LIMITED TO PAIN, SWELLING, AND LACK OF MOBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 48 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2138409

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention