BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 4100040 · Received September 18, 2014

    Report

    Report Number
    1818910-2014-28403
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    January 11, 2012
    Report Date
    August 29, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    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. 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 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.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER WPC (B)(4). REASON FOR ORIGINAL COMPLAINT - PATIENT WAS REVISED TO ADDRESS ACETABULAR CUP LOOSENING AND INFECTION. UPDATE REC¿D 8/29/2014 - LITIGATION RECEIVED. LITIGATION ALLEGES INJURY, PAIN, AND ELEVATED METAL ION LEVELS. THE EXISTING MDR DECISION HAS BEEN REVERSED AND HEAD HAS BEEN REPORTED. THIS COMPLAINT WAS UPDATED ON: 9/18/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578497 ASR UNI FEMORAL IMPL SIZE 51 HIP FEMORAL HEAD KWA DEPUY INTL., LTD - 8010379 2171743

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention