BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 3012048 · Received March 20, 2013

    Report

    Report Number
    1818910-2013-01664
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    May 14, 2014
    Report Date
    July 21, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. NOT RECEIVED.

    Description of Event or Problem · 1

    UPDATE REC'D 7/21/2014 - MEDICAL RECORDS RECEIVED. PATIENT REVISED TO ADDRESS PAIN. UPON REVISION, POSTERIOR SUBLUXATION OF THE HIP WAS NOTED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THIS COMPLAINT WAS UPDATED ON: 07/28/2014.

    Description of Event or Problem · 1

    NEW (B)(6) RECORD CREATED IN ORDER TO UPDATE (B)(6) (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - PATIENT IS SEEKING LEGAL ACTION. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2006 DOR: NONE SCHEDULED AT THIS TIME. (LEFT SIDE). PATIENT IS A RESIDENT OF (B)(6). UPDATE DER RCVD 21 MAY 2014 - UPDATED DOR, PATIENT DEMOGRAPHICS, SURGEON AND HOSPITAL.

    Description of Event or Problem · 1

    PATIENT IS SEEKING LEGAL ACTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116246 ASR UNI FEMORAL IMPL SIZE 49 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL 2097964

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R