BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 2944686 · Received February 5, 2013

    Report

    Report Number
    1818910-2013-01644
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    August 27, 2012
    Report Date
    May 6, 2015
    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
    IL, 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. (B)(4).

    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. 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 AND/OR CORRECTIVE ACTIONS.  REF. WWCAPA (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

    LITIGATION PAPERS ALLEGE THE ASR PROSTHESIS IN THE PATIENTS RIGHT HIP FAILED RESULTING IN METAL PARTICLES OR IONS ENTERING THE SURROUNDING TISSUE CAUSING A DETERIORATION OF THE TISSUE AND ENTERING INTO THE BLOODSTREAM THROUGH WHICH THEY WERE DISTRIBUTED THROUGHOUT VARIOUS PARTS OF THE BODY THEREBY CAUSING METAL POISONING. THE PATIENT UNDERWENT REVISION SURGERY AS A RESULT OF THE FAILURE AND SUFFERED GREAT PAIN AND A DIMINISHED CAPACITY TO LEAD A NORMAL LIFE.

    Description of Event or Problem · 1

    UPDATE REC'D 5/6/2015- PPD AND MEDICAL RECORDS. RECEIVED. PPD AND MEDICAL RECORDS WERE RECEIVED ON 12/2/2013 WITH THE ALERT DATE OF (B)(6) 2013. THESE RECORDS WERE REVIEWED FOR MDR REPORTABILITY ON 5/6/2015. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED PAIN AND METAL WEAR DEBRIS. NO LABS WERE PROVIDED FOR THE ALLEGED HIGH METAL IONS. THE STEM IS BEING ADDED FOR THE HIGH METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48561 ASR UNI FEMORAL IMPL SIZE 45 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2637983

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention