BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 4130897 · Received September 30, 2014

    Report

    Report Number
    1818910-2014-29152
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    February 18, 2015
    Report Date
    February 18, 2015
    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
    MT, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.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.(B)(4).

    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 THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PAIN, FLUID AND EXCESSIVE METAL ION LEVELS.

    Description of Event or Problem · 1

    UPDATE 18 FEB 2015 - DER RCVD. ADDED DOR, SURGEON AND SALES REP DETAILS, ADDED STEM AND SLEEVE AND UPDATED CUP AND HEAD TO REFLECT THE METAL IONS. STEM REMAINED IN SITU. (B)(6)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608238 ASR UNI FEMORAL IMPL SIZE 47 HIP FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 2551512

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| R