BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 58

    MDR report key: 2993813 · Received March 8, 2013

    Report

    Report Number
    1818910-2013-04187
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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

    LITIGATION ALLEGES PATIENT WAS PERMANENTLY HARMED BY SEVERE METAL POISONING AND METALLOSIS FROM METAL DEBRIS AFTER ASR HIP IMPLANT. DEPUY STILL 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 INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO CYST WITH REACTIVE FLUID WITH HIGH LYMPHOCYTE COUNTS ALONG LATERAL ASPECT OF GREATER TROCHANTER COMING FROM ACETABULAR COMPONENT. PATIENT COMPLAINED OF BURNING SENSATION. UPDATE: (B)(6) 2013 - LITIGATION RECEIVED (B)(6) 2013 AND ATTACHED. COMPLAINT CHANGED TO LEGAL. DOB ADDED. LITIGATION ALLEGES PATIENT WAS PERMANENTLY HARMED BY SEVERE METAL POISONING AND METALLOSIS FROM METAL DEBRIS AFTER ASR HIP IMPLANT. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE: (B)(6) 2013 - PLAINTIFFS PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION AND CORRECT IMPLANT DATE. 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 WAS REVISED DUE TO CYST WITH REACTIVE FLUID WITH HIGH LYMPHOCYTE COUNTS ALONG LATERAL ASPECT OF GREATER TROCHANTER COMING FROM ACETABULAR COMPONENT. PATIENT COMPLAINED OF BURNING SENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99840 ASR ACETABULAR CUPS 58 ACETABULAR CUP KWA DEPUY INTERNATIONAL 2123922

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention