BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 3192763 · Received June 27, 2013

    Report

    Report Number
    1818910-2013-19972
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 20, 2013
    Report Date
    October 4, 2013
    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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. REF. (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 THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    **UPDATE**(B)(4) 2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES DISCOMFORT AND ELEVATED METAL ION LEVELS. DOI PROVIDED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT UNDERWENT LEFT HIP REVISION PROCEDURE DUE TO PAIN AND OSTEOLYSIS.

    Description of Event or Problem · 1

    **UPDATE** - MEDICAL RECORDS RECEIVED (B)(4) 2013. REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: LOOSE CUP; METALLOSIS; PAIN; MINIMAL ELEVATED COBALT AND CHROMIUM LEVELS; 5 ML OF THICK MUCINOUS WATERY FLUID WITH A SLIGHTLY GRAYISH APPEARANCE; SCAR TISSUE; GRAYISH AND METAL STAINED SYNOVIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292120 ASR UNI FEMORAL IMPL SIZE 46 FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 2050175

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention