BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 41

    MDR report key: 4133799 · Received October 1, 2014

    Report

    Report Number
    1818910-2014-29228
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KXA
    PMA / PMN Number
    PK040627
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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 CASE CLOSED TO CAPA.

    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. 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. WWCAPA (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. THIS COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PAIN, CLICKING, LIMITED MOBILITY, LOOSENING, POPPING, FLUID BUILD-UP, PSEUDOTUMOR, NECROSIS, AND ELEVATED METAL IONS LEVELS.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PAIN, CLICKING, LIMITED MOBILITY, LOOSENING, POPPING, FLUID BUILD-UP, PSUTODUMOR, NECROSIS, ADN ELEVATED METAL IONS LEVELS.UPDATE DER RCVD. UPDATED DOR, REMOVED LOOSENING AS DER STATES NO LOOSENING. ADDED PATIENT ACTIVITY LEVEL, AGE AND DOB. ADDED SURGEON AND SLAES REP DETAILS. UPDATED PRODUCTS HOWEVER NO LOT NUMBERS AVAILABLE AND ADDED SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610744 ASR UNI FEMORAL IMPL SIZE 41 HIP FEMORAL HEAD KXA DEPUY INTL., LTD. - 8010379 999890241 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Other| R