BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 41

    MDR report key: 3191047 · Received June 26, 2013

    Report

    Report Number
    1818910-2013-06309
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    July 8, 2020
    Report Date
    December 1, 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
    IN, 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT HAS EXPERIENCED PAIN, SWELLING AND DIFFICULTY WALKING SINCE HER ORIGINAL HIP REPLACEMENT SURGERY AND WILL UNDERGO FURTHER MEDICAL OPERATIONS TO REMOVE THE HIP PROSTHESIS AND REPLACE IT WITH ANOTHER HIP PROSTHESIS.UPDATE (B)(4) 2012 - RECORDS FOR STATE COURT PLAINTIFFS RECEIVED 5/30/2012. CHANGED UNK ASR HIP TO ASR CUP ADDED FEMORAL HEAD.

    Description of Event or Problem · 1

    UPDATE REC'D 12/1/2014 ADDITIONAL LITIGATION RECEIVED. LITIGATION ALLEGES ELEVATED METAL ION LEVELS. THE STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291055 ASR UNI FEMORAL IMPL SIZE 41 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2077664

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R ADAPTER SLEEVES 12/14 +5| ASR ACETABULAR CUPS 46| SUMMIT POR TAPER SZ3 STD OFF