BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2122752 · Received June 3, 2011

    Report

    Report Number
    1818910-2011-09490
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 4, 2011
    Report Date
    November 10, 2013
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL 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 THIS INVESTIGATION 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS HIP PAIN AND CLICKING. UPON EXCISION OF THE CAPSULE, COPIOUS AMOUNTS OF GRAY, MILKY FLUID WAS EXPELLED. THE ACETABULAR CUP WAS LOOSE. ADDITIONAL INFORMATION: LITIGATION PAPERS ALLEGE THE PATIENT SUFFERED PAIN AND HAD HIGH CONCENTRATIONS OF VARIOUS METALLIC ELEMENTS IN HER BLOOD.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE PATIENT WAS REVISED DUE TO BULGING SOFT TISSUE, GRAY STAINED CAPSULE AND SYNOVIAL LINING WITH SOME DEGENERATIVE APPEARANCE TO THE TISSUE FROM METALLIC WEAR, AND BULGING SOFT TISSUE. UPON REVISION, THE CUP WAS FOUND TO HAVE NO BONE INGROWTH, JUST FIBROUS INGROWTH. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS HIP PAIN AND CLICKING. UPON EXCISION OF THE CAPSULE, COPIOUS AMOUNTS OF GRAY, MILKY FLUID WAS EXPELLED. THE ACETABULAR CUP WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2573244

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention