BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR 300 SPIKED CUP SIZE 56

    MDR report key: 3070130 · Received April 22, 2013

    Report

    Report Number
    1818910-2013-04854
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    January 27, 2014
    Report Date
    April 7, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK073413
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED DOB AND PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. COMPLAINT UPDATED (B)(4) 2013.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN AND EXTREME WEAKNESS; STIFFNESS AND LIMITED AMBULATORY CAPABILITIES; DAMAGE TO BONES IN HIP; AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT AFTER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    UPDATE: 04/07/2014 - MEDICAL RECORDS RECEIVED. UPON REVISION, YELLOW FLUID WITH BLACK SPICULES CONSISTENT WITH METALLOSIS AND CORROSION WERE NOTED. THE ADAPTER SLEEVE AND FEMORAL STEM ARE NOW BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: 04/27/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172090 ASR 300 SPIKED CUP SIZE 56 ACETABULAR CUP KWA DEPUY INTERNATIONAL 2842738

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other