BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 43

    MDR report key: 2883719 · Received December 21, 2012

    Report

    Report Number
    1818910-2012-26025
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    April 2, 2015
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    UPDATE: (B)(4) 2013 - SALES REP REPORTED REVISION SURGERY FOR RIGHT HIP. PATIENT WAS REVISED TO ADDRESS IMPLANT LOOSENING, PAIN, OSTEOLYSIS, AND ELEVATED METAL IONS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE PATIENT SUFFERED PAIN, DISCOMFORT, SORENESS, MALAISE, SWELLING, DECREASED MOBILITY, DAMAGE TO SURROUNDING BONE AND TISSUE AND EXPOSURE TO EXCESSIVE LEVELS OF CHROMIUM AND COBALT AS A RESULT OF THE IMPLANTED ASR HIP.

    Description of Event or Problem · 1

    UPDATE REC'D 4/2/2015- PPD WITH MEDICAL RECORDS FOR BOTH HIP REVISIONS RECEIVED. UPON REVISION OF THE PATIENT'S LEFT HIP, METALLOSIS, METAL DEBRIS, BURNISHING ON THE TRUNNION, OSTEOPHYTES, AND CLOUDY FLUID WERE NOTED. UPON REVISION OF THE RIGHT HIP, A PSEUDOTUMOR/PSEUDOCYST WITH GREEN CHALKY MATERIAL, METALLIC WEAR DEBRIS, AND BURNISHING OF THE FEMORAL NECK WERE NOTED. BOTH STEMS REMAINED IN SITU. THE LEFT STEM AND RIGHT STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON 04/09/15.

    Description of Event or Problem · 1

    NEW ETQ CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) (B)(4). REASON FOR ORIGINAL COMPLAINT- LITIGATION ALLEGED THE PATIENT SUFFERED PAIN, DISCOMFORT, SORENESS, MALAISE, SWELLING, DECREASED MOBILITY, DAMAGE TO SURROUNDING BONE AND TISSUE AND EXPOSURE TO EXCESSIVE LEVELS OF CHROMIUM AND COBALT AS A RESULT OF THE IMPLANTED ASR HIP. UPDATE 1/22/2013 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE 10/29/2013 - SALES REP REPORTED REVISION SURGERY FOR RIGHT HIP. PATIENT WAS REVISED TO ADDRESS IMPLANT LOOSENING, PAIN, OSTEOLYSIS, AND ELEVATED METAL IONS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. UPDATE REC'D 23 APR 2014: DOR FOR LEFT HIP, PATIENT'S AGE, WEIGHT, ACTIVITY LEVEL, PMA/510K NUMBER, SALE REP DETAILS, SURGEON, EACH PRODUCT'S CONSTRUCT TYPE, COMMON NAME AND BRAND NAME, HOSPITAL. RELEVANT TEST/LAB DATA, COMPLAINT CATEGORY - PRODUCT RELATED, ADDITIONAL TAPER SLEEVE. HOSPITAL: (B)(6). UNABLE TO ENTER INTO COMPLAINANT INFORMATION SECTION DUE TO COMPLAINT BEING LEGAL.

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE PATIENT SUFFERED PAIN, DISCOMFORT, SORENESS, MALAISE, SWELLING, DECREASED MOBILITY, DAMAGE TO SURROUNDING BONE AND TISSUE AND EXPOSURE TO EXCESSIVE LEVELS OF CHROMIUM AND COBALT AS A RESULT OF THE IMPLANTED ASR HIP. **UPDATE** 1/22/2013 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED PART/LOT INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 43 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL 2170045

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other