BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SROM*STM ST,30+4L NK,18X13X160

    MDR report key: 2990333 · Received March 5, 2013

    Report

    Report Number
    1818910-2013-04041
    Event Type
    Injury
    Date Received
    March 5, 2013
    Report Date
    February 7, 2013
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    JDI
    PMA / PMN Number
    K851422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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. DOI: (B)(6) 2006, DOR: (B)(6) 2008. 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 - (B)(4) 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. DOI: (B)(6) 2006 (LEFT SIDE). EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    Additional Manufacturer Narrative · 1

    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. DOI: (B)(6) 2006 DOR: (B)(6) 2008. UPDATE: (08/29/2012), LITIGATION PAPERS RECEIVED 08/01/2012 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. DOI: (B)(6) 2006 (LEFT SIDE). EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    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.

    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** (08/29/2012) LITIGATION PAPERS RECEIVED (B)(6) 2012. 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 #150; 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93204 SROM*STM ST,30+4L NK,18X13X160 STEM JDI DEPUY RAYNHAM 2206162

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention