BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 4260167 · Received November 18, 2014

    Report

    Report Number
    1818910-2014-31894
    Event Type
    Injury
    Date Received
    November 18, 2014
    Date of Event
    March 13, 2015
    Report Date
    March 13, 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
    ME, 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.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.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.

    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 THE INVESTIGATION CLOSED

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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).

    Description of Event or Problem · 1

    UPDATE (B)(4) 2015: DER REC'D, PATIENT DEMOS - WEIGHT & HEIGHT, SURGEON, REVISION CONFIRMED - (B)(6) 2015, INCREASING METAL IONS, SALES REP DETAILS, HIP SIDE - RIGHT, ALL MW FIELDS.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE ALVAL, PAIN, DISCOMFORT, POOR BALANCE, DIFFICULTY WALKING, NOISES; POPPING, CLICKING, AND GRINDING, BONE EROSION, FEMORAL ACETABULAR LOOSENING, IMPINGEMENT AND/OR DETACHMENT, AND METALLOSIS.

    Description of Event or Problem · 1

    UPDATE REC'D 12/12/14 - PLAINTIFF¿S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED SIDE, DOB, AND PART/LOT INFORMATION. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746711 ASR UNI FEMORAL IMPL SIZE 45 HIP FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 2291341

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R