BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 3260626 · Received August 1, 2013

    Report

    Report Number
    1818910-2013-22803
    Event Type
    Injury
    Date Received
    August 1, 2013
    Date of Event
    July 31, 2013
    Report Date
    January 20, 2014
    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
    FL, 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

    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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    UPDATE: (B)(6) 2014 - MEDICAL RECORDS RECEIVED. PATIENT WAS REVISED TO ADDRESS METALLOSIS, SYNOVITIS, CLOUDY FLUID, CORROSION BETWEEN THE HEAD AND STEM, AND NO BONE INGROWTH ON THE ACETABULAR CUP. THE STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: (B)(6) 2014.

    Description of Event or Problem · 1

    PATIENT UNDERWENT REVISION PROCEDURE DUE TO UNKNOWN REASONS.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN, INJURY TO THE BODY AND EXTREMITIES AND ELEVATED METAL ION LEVELS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360430 ASR ACETABULAR CUPS 54 ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 2293541

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention