BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY SLEEVE

    MDR report key: 3143075 · Received June 3, 2013

    Report

    Report Number
    1818910-2013-18066
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    January 23, 2013
    Report Date
    May 4, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT 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. LITIGATION ALLEGES THAT THE PATIENT CONTINUES TO EXPERIENCE HARM AND DAMAGES. DOI: (B)(6) 2008 - DOR: (B)(6) 2008 (METAL LINER). DOR: (B)(6) 2012 (POLY LINER/HEAD) (RIGHT HIP). UPDATE: (B)(4) 2013 - PFS AND MEDICAL RECORDS RECEIVED. OPERATIVE NOTES INDICATE THAT THE PATIENT SUFFERED FROM A LOOSE STEM AND SLEEVE. IT IS ADDITIONALLY ALLEGED THAT THE LINER WAS LOOSE WITHIN THE CUP. AN UNKNOWN STEM AND SLEEVE HAVE BEEN ADDED. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. MEDICAL RECORDS WERE RECEIVED AND REVIEWED BY THE DEPUY LEGAL NURSE. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE, IT IS UNLIKELY THE COMPLAINT IS PRODUCT RELATED. ANY TOTAL JOINT ARTHROPLASTY HAS A RISK OF FAILURE THAT IS DUE TO A COMBINATION OF UNKNOWN FACTORS THAT INCLUDE PATIENT FACTORS, SURGICAL PROCESS AND SURGICAL TECHNIQUE. IN THIS CASE IT APPEARS THE SURGICAL TECHNIQUE AND PLACEMENT OF THE COMPONENTS MAY HAVE CONTRIBUTED TO THE MULTIPLE REVISIONS. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT CONTINUES TO EXPERIENCE HARM AND DAMAGES. UPDATE: (B)(6) 2013- PFS AND MEDICAL RECORDS RECEIVED. OPERATIVE NOTES INDICATE THAT THE PATIENT SUFFERED FROM A LOOSE STEM AND SLEEVE. IT IS ADDITIONALLY ALLEGED THAT THE LINER WAS LOOSE WITHIN THE CUP. AN UNKNOWN STEM AND SLEEVE HAVE BEEN ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245069 UNKNOWN DEPUY SLEEVE FEMORAL SLEEVE JWH DEPUY ORTHOPAEDICS INC US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other