BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SLEEVE SZ9 HI OFF

    MDR report key: 2974448 · Received February 22, 2013

    Report

    Report Number
    1818910-2013-03914
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    March 26, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE 3/26/2013 - PPD RECEIVED. PAR/LOT HAS BEEN UPDATED FOR THE STEM. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. UPDATED INFORMATION INDICATES CORROSION WAS FOUND ON THE TRUNNION. THE MEDICAL RECORDS INDICATE THE REPORTED CORROSION WAS WIPED OFF THE IMPLANT. PRODUCT AND LOT CODE WAS NOT PROVIDED. A SEARCH OF THE COMPLAINTS DATABASES AND/OR REVIEW OF DEVICE HISTORY RECORDS IS THEREFORE NOT POSSIBLE. 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).

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE, THE PATIENT SUFFERS FROM ELEVATED METAL ION LEVELS. UPDATE: 11/28/2012 - THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS PAIN AND FLUID. UPDATE: 02/05/2013 - MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATES CORROSION ON THE TAPER WAS NOTED INTER OPERATIVELY. THE STEM AND SLEEVE WERE ADDED TO COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78588 SUMMIT POR TAPER SLEEVE SZ9 HI OFF TOTAL HIP REPLACEMENT KWY DEPUY INTERNATIONAL AS3FF1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention