BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 43

    MDR report key: 3143719 · Received June 3, 2013

    Report

    Report Number
    1818910-2013-18096
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    December 22, 2014
    Report Date
    February 5, 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
    TX, US
    Reporter Occupation
    ATTORNEY

    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 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

    THE CORRECTION MADE WAS FOR THE COMPLETED ADDRESS AND DEPUY STILL CONSIDERS THIS CASE 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

    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.(B)(4)

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, POPPING AND GRINDING, RASH THAT CONTINUES TO COME AND GO AT THE INCISION SITE, AND ELEVATED METAL ION LEVELS.

    Description of Event or Problem · 1

    UPDATE REC'D 2/5/2015 - MEDICAL RECORDS RECEIVED. UPON REVISION, FLUID, METALLOSIS, AND DARK STAINED TISSUE WERE NOTED. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, POPPING AND GRINDING, RASH THAT CONTINUES TO COME AND GO AT THE INCISION SITE, AND ELEVATED METAL ION LEVELS.UPDATE DER RCVD - UPDATED DOR, SALES REP AND SURGEON DETAILS AND UPDATED HEAD AND CUP DETAILS AND ADDED STEM AND SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243572 ASR UNI FEMORAL IMPL SIZE 43 HIP FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 2192976

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R