BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 1193492 · Received October 3, 2008

    Report

    Report Number
    1818910-2008-04626
    Event Type
    Injury
    Date Received
    October 3, 2008
    Report Date
    September 16, 2008
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    EXAMINATION IS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. REVIEW OF PROVIDED PT X-RAYS IS UNABLE TO CONCLUSIVELY DETERMINE A ROOT CAUSE FOR THE REPORT. AN ETQ COMPLAINT DATABASE SEARCHES MADE ON PRODUCT LOT 2254219 IDENTIFIED NO SIMILAR COMPLAINTS RECEIVED PREVIOUSLY. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. MONITOR THROUGH TREND ANALYSIS.

    Description of Event or Problem · 1

    PATIENT IS COMPLAINING OF PAIN. REVISION SURGERY HAS NOT BEEN PERFORMED AT THIS TIME. REPORT RECEIVED FROM THE FDA STATING: GROIN PAIN AND POPPING OF HIP REPLACEMENT PROSTHESIS. INTRAOPERATIVELY, IT WAS DISCOVERED THAT THE ACETABULAR CUP HAD SHIFTED CAUSING METAL ON BONE RUBBING. THERE WAS NO BONY INGROWTH IN THE CUP. UPDATE: ((B)(4) 2012), LITIGATION PAPERS RECEIVED (B)(4) 2012 AND ATTACHED. COMPLAINT CHANGED TO LEGAL. LITIGATION STATES LEFT HIP. PRODUCT HEAD ADDED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION EXCEPT PRODUCT HEAD NOW REPORTED. UPDATE: 2/7/2013; PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED SIDE AND CORRECT IMPLANT DATE. MEDICAL RECORDS WERE ALSO RECEIVED, WHICH INDICATED THAT AN INTERIOR CRACK WAS NOTED DURING INSERTION. THE STEM AND SLEEVE ARE NOW BEING REPORTED. COMPLAINT HAS BEEN REOPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    THE PT WAS REVISED BECAUSE OF GROIN PAIN AND POPPING OF HIP REPLACEMENT PROSTHESIS. INTRAOPERATIVELY, IT WAS DISCOVERED THAT THE ACETABULAR CUP HAD SHIFTED CAUSING METAL ON BONE RUBBING. THERE WAS NO BONY INGROWTH IN THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 50 87KWA KWA DEPUY INTL, LTD. NA 2254219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention