BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 3870912 · Received June 12, 2014

    Report

    Report Number
    1818910-2014-20924
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 23, 2014
    Report Date
    July 11, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.-8010379
    Product Code
    KXA
    PMA / PMN Number
    PK040627
    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 THIS INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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.

    Description of Event or Problem · 1

    UPDATE REC¿D 7/11/2014 - MEDICAL RECORDS RECEIVED. UPON REVISION, TISSUE DISCOLORATION, GREY BURSAL TISSUE, METALLIC WEAR, AND A SMALL AMOUNT OF DISCOLORATION ON THE MORSE TAPER WITH NO CORROSION WERE NOTED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON: 07/16/2014.

    Description of Event or Problem · 1

    ASR REVISION REPORTED VIA SALES REP; ASR XL; RIGHT. REASON(S) FOR REVISION : PAIN / HIGH COCR LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347411 ASR UNI FEMORAL IMPL SIZE 46 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD.-8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention