BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEM EXTENSION, OFFSET

    MDR report key: 2231039 · Received August 26, 2011

    Report

    Report Number
    1822565-2011-01961
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY - BASED ON THE INFO AVAILABLE, THE CAUSE FOR THE REPORTED ISSUE IS DAMAGE TO THE LEAD THREAD OF THE OFFSET STEM EXTENSION. THE ORIGINATION/CAUSE OF THE DEFORMATION DAMAGE IS UNK. NO OTHER COMPLAINTS HAVE BEEN RECEIVED AGAINST THIS ITEM FOR SAME OR SIMILAR CONDITIONS. ADDITIONALLY, THERE ARE NO OTHER COMPLAINTS AGAINST THIS ITEM/LOT COMBINATION. EVAL - THE PROXIMAL END OF THE OFFSET EXTENSION EXHIBITS DAMAGE TO THE RETAINING SCREW HOLE. IT APPEARS THE STEM EXTENSION CAME INTO CONTACT WITH AN OBJECT OF APPROX 4MM WIDTH. THE RETAINING SCREW HOLE WOULD NOT ACCEPT THE THREADED PLUG GAUGE. AN ATTEMPT WAS MADE TO ATTACH THE SCREW TO THE OFFSET EXTENSION WHICH YIELDED APPROX THREE TURNS PRIOR TO THE DEVICE SEIZING. THE OFFSET STEM UTILIZES A SPIRAL LOCK MODIFIED THREAD TO HELP PREVENT THE SCREW FROM BACKING OUT OF THE DEVICE WHICH EXPLAINS WHY THE SCREW WOULD ENTER THREE TURNS INTO THE EXTENSION PRIOR TO SEIZING. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPEC. NO MFG ABNORMALITIES COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW COULD NOT BE FULLY THREADED INTO THE OFFSET STEM EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN STEM EXTENSION, OFFSET JWH ZIMMER, INC. 61116282

    Patients

    Seq Age Sex Outcome Treatment
    1