BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 2980375 · Received February 27, 2013

    Report

    Report Number
    1818910-2013-02717
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    April 9, 2014
    Report Date
    May 8, 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
    GA, US
    Reporter Occupation
    ATTORNEY

    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. (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

    **UPDATE** (B)(4) 2013 - PPD RECEIVED. PART/LOT INFORMATION FOR THE RIGHT HIP. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY CONSIDERS THIS COMPLAINT CLOSED AT THIS TIME.

    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 THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE PATIENT WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD AS A RESULT OF THE IMPLANTED ASR HIP.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - LITIGATION ALLEGED THE PATIENT WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD AS A RESULT OF THE IMPLANTED ASR HIP. DOI: (B)(6) 2008 - DOR: NONE REPORTED (RIGHT HIP). PT IS A RESIDENT OF THE STATE OF (B)(6). UPDATE - 3/8/13 - PPD RECEIVED. PART/LOT INFORMATION FOR THE RIGHT HIP. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE - 9 APRIL 2014 - DER RECEIVED. HOSPITAL/SURGEON INFORMATION. CONFIRMED PAIN AS WELL AS METALLOSIS. CONFIRMATION OF FURTHER PRODUCT.

    Description of Event or Problem · 1

    UPDATE REC'D 5/8/2014 - MEDICAL RECORDS RECEIVED. PATIENT REVISED TO ADDRESS EFFUSION. UPON REVISION, OSTEOLYSIS, GRAY STAINING, BROWNISH CLEAR SYNOVIAL FLUID, BROWNISH STAINED TISSUE, CORROSION ON THE TRUNNION. DURING REMOVAL OF THE STEM, A 5 MM FRACTURE OCCURRED IN THE TROCHANTER. THE SLEEVE IS NOW BEING REPORTED AND STEM AND SROM SLEEVE ARE BEING ADDED TO THE COMPLAINT. UPDATE MADE TO THE SROM STEM AFTER COMPLAINT WAS TRAIGED. THIS COMPLAINT WAS UPDATED ON: 05/29/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83337 ASR UNI FEMORAL IMPL SIZE 45 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL 2550547

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| R