BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 53

    MDR report key: 3181085 · Received June 20, 2013

    Report

    Report Number
    1818910-2013-19447
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    August 4, 2014
    Report Date
    October 28, 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
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT IS CONSIDERED CLOSED.

    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

    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

    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.

    Description of Event or Problem · 1

    LITIGATION PAPERS RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM PAIN AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT.

    Description of Event or Problem · 1

    LITIGATION PAPERS RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM PAIN AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT. UPDATE ((B)(6) 2013) - PATIENT FACT SHEET WAS RECEIVED. THE PART/LOT NUMBERS HAVE BEEN UPDATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE DER REC'D (B)(6) 2014 - ADDED DOR, SURGEON NAME, 510K NUMBERS AND SLEEVE.

    Description of Event or Problem · 1

    UPDATE REC'D 10/28/2014 MEDICAL RECORDS RECEIVED. UPON REVISION, A PSEUDOTUMOR AND BLACKENED TISSUE CONSISTENT WITH CORROSION AT THE TRUNNION WERE NOTED. THE STEM IS BEING ADDED TO THE COMPLAINT. THE STEM REMAINED IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280148 ASR UNI FEMORAL IMPL SIZE 53 HIP FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 2826567

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other| R