BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 48

    MDR report key: 3241757 · Received July 22, 2013

    Report

    Report Number
    1818910-2013-21851
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    December 10, 2013
    Report Date
    February 6, 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
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 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.

    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.

    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.

    Description of Event or Problem · 1

    **UPDATE** - SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS PSEUDOTUMOR. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: (B)(4) 2013.

    Description of Event or Problem · 1

    UPDATE: (B)(4) 2014 - MEDICAL RECORDS RECEIVED. PATIENT WAS REVISED TO ADDRESS METALLOSIS, BROWNISH LIQUID, BLACK DISCOLORATION, SYNOVITIS, AND STEM CORROSION. THE SLEEVE AND STEM ARE BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Description of Event or Problem · 1

    LITIGATION RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM PAIN AND EXCESSIVE CHROMIUM COBALT LEVELS. ALSO ALLEGED MRI OF LEFT HIP SHOWING INTEROSSEOUS CYSTS OF THE GREATER TROCHANTER AND DEEP TO THE GLUTEUS TENDON WITH MATERIAL INSIDE THE CYST THAT MAY REFLECT AN ADVERSE TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341720 ASR ACETABULAR CUPS 48 ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 2177251

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other