BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR ACETABULAR CUP

    MDR report key: 2840615 · Received November 20, 2012

    Report

    Report Number
    1818910-2012-24100
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    August 13, 2013
    Report Date
    November 10, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. 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 INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE, THE PATIENT EXPERIENCED PAIN AND HAD HIGH CONCENTRATIONS OF VARIOUS METALLIC ELEMENTS IN HER BLOOD AS A RESULT OF THE FAILED ASR.

    Description of Event or Problem · 1

    UPDATE: (B)(6) 2013 - MEDICAL RECORDS FOR BOTH HIPS WERE OBTAINED. MEDICAL RECORDS INDICATE PATIENT WAS REVISED ON THE LEFT SIDE DUE TO GLASSY SUBFASCIAL SPACE FROM VENTING, BLACK STAINING OF THE INTRAARTICULAR SPACE WITH GRANULAR TYPE MATERIAL AND A THICKENED CAPSULE. UPON REVISION OF THE LEFT HIP, NO BONE ATTACHED TO THE CUP, DARK TINGED SEROSANGUINEOUS FLUID AND A DRY, THICKENED CAPSULE WERE FOUND. MEDICAL RECORDS INDICATE PATIENT WAS REVISED ON THE RIGHT SIDE DUE TO A LARGE EFFUSION WITH TURBID, GRAY TO BLACK STAINED FLUID AND EXTENSIVE BLACK CHANGES OF THE CAPSULE. UPON REVISION OF THE RIGHT HIP, NO BONE INGROWTH ON THE CUP, BLACKENED TISSUE, POOR CONDITION OF THE POSTERIOR CAPSULE AND HETEROTOPIC OSSIFICATION WERE FOUND. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR ACETABULAR CUP ACETABULAR CUP HIP IMPLANT KWA DEPUY INTERNATIONAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other