BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS FEMORAL STEM

    MDR report key: 2875133 · Received December 12, 2012

    Report

    Report Number
    1822565-2012-02527
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    May 29, 2007
    Report Date
    November 14, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PATIENT HAD PREVIOUSLY UNDERGONE A RIGHT HIP SURGERY, INCLUDING A GREATER TROCHANTERIC OSTEOTOMY FOR A TROCHANTERIC OVERGROWTH AND ACETABULAR RECONSTRUCTION. SURGICAL TECHNIQUE INSTRUCTS TO PRESS THE IMPLANT DOWN THE CANAL BY HAND UNTIL IT WILL NO LONGER ADVANCE, AND THEN USE THE STEM IMPACTOR AND MALLET UNTIL THE PROSTHESIS IS FULLY SEATED OR WILL NO LONGER ADVANCE. IF THE IMPLANT IS NOT ADVANCING BEFORE BEING FULLY SEATED, IT SHOULD BE REMOVED AND THE FEMORAL CANAL SHOULD BE RE-RASPED. IT IS LIKELY THAT USER ERROR, IN COMBINATION WITH THE PATIENT'S PRE-EXISTING MEDICAL HISTORY HAS CONTRIBUTED TO THE EVENT DESCRIBED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT UPON IMPACTION OF THE STEM, THE MEDIAL POSTERIOR NECK WAS CRACKED. THE STEM WAS OVER INSERTED AND THE SURGEON HAD TO REMOVE THE STEM AND THEN PLACE 2 CABLE WIRES AROUND THE PROXIMAL FEMUR SO AS TO NOT EXTEND THE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS FEMORAL STEM MEH ZIMMER, INC. 60509797

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention