BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 2122054 · Received June 9, 2011

    Report

    Report Number
    1818910-2011-10351
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    January 31, 2011
    Report Date
    May 10, 2011
    Manufacturer
    DEPUY INTL. LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT STATES: LITIGATION PAPERS ALLEGE IN THE YEAR FOLLOWING SURGERY, PATIENT SUFFERED FROM DISCOMFORT AND PAIN IN HER HIP. IT BECAME INCREASINGLY PAINFUL FOR HER TO WALK, TO MOVE HER LEGS, AND TO RISE FROM A SEATED POSITION. IT IS FURTHER ALLEGED THAT FOUR YEARS AFTER PATIENT RECEIVED HER IMPLANTS, HER TREATING ORTHOPEDIC SURGEON CONCLUDED THAT THE HIP IMPLANT HAD FAILED AND NEEDED TO BE REPLACED. DOI: (B)(6) 2008 - DOR: (B)(6) 2011 (UNKNOWN SIDE). PATIENT IS A RESIDENT OF (B)(6). 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 THE INVESTIGATION CLOSED.

    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

    CORRECTED: EVENT/PROBLEM DESCRIPTION, IMPLANT DATE, DATE RECEIVED BY MANUFACTURER. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE IN THE YEAR FOLLOWING SURGERY, PATIENT SUFFERED FROM DISCOMFORT AND PAIN IN HER HIP. IT BECAME INCREASINGLY PAINFUL FOR HER TO WALK, TO MOVE HER LEGS, AND TO RISE FROM A SEATED POSITION. IT IS FURTHER ALLEGED THAT FOUR YEARS AFTER PATIENT RECEIVED HER IMPLANTS, HER TREATING ORTHOPEDIC SURGEON CONCLUDED THAT THE HIP IMPLANT HAD FAILED AND NEEDED TO BE REPLACED. UPDATE: (B)(4) 2011 - THE REVISION OPERATIVE REPORT WAS RECEIVED. IT IS INDICATED THAT A LARGE AMOUNT OF FLUID WAS REMOVED. ADDITIONALLY THERE WAS A METALLOID REACTION WITH GREENISH HUE TO THE TISSUE. THE COMPLAINT WAS REOPENED TO ADD AN ADDITIONAL PRODUCT. UPDATE: (B)(4) 2011 - PLAINTIFF FACT SHEET RECEIVED. PART AND LOT WERE IDENTIFIED. THERE IS NO NEW INFO THAT WOULD CHANGE INVESTIGATION. UPDATE: (B)(4) 2011 - PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED IMPLANT DATE. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE IN THE YEAR FOLLOWING SURGERY, PT SUFFERED FROM DISCOMFORT AND PAIN IN HER HIP. IT BECAME INCREASINGLY PAINFUL FOR HER TO WALK, TO MOVE HER LEGS, AND TO RISE FROM A SEATED POSITION. IT IS FURTHER ALLEGED THAT FOUR YEARS AFTER PT RECEIVED HER IMPLANTS, HER TREATING ORTHOPEDIC SURGEON CONCLUDED THAT THE HIP IMPLANT HAD FAILED AND NEEDED TO BE REPLACED. UPDATE (B)(6) 2011 - THE REVISION OPERATIVE REPORT WAS RECEIVED. IT IS INDICATED THAT A LARGE AMOUNT OF FLUID WAS REMOVED. ADDITIONALLY THERE WAS A METALLOID REACTION WITH GREENISH HUE TO THE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 45 TOTAL HIP REPLACEMENT KWA DEPUY INTL. LTD. NA 2559666

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention