BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TRABECULAR METAL HUMERAL STEM

    MDR report key: 1940903 · Received December 23, 2010

    Report

    Report Number
    1822565-2010-01461
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 3, 2010
    Manufacturer
    ZIMMER INC
    Product Code
    HSD
    Removal / Correction Number
    1822565-7/26/2010-006-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS REC'D FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: A MODIFIED SURGICAL TECHNIQUE WAS RELEASED IN (B)(4) 2010 BY ZIMMER FOR BOTH THE TM HUMERAL AND TM REVERSE SHOULDER SYSTEMS WHICH REQUIRES REAMING 1MM LARGER THAN THE INTENDED IMPLANT SIZE. THIS NEW SURGICAL TECHNIQUE WAS RELEASED AS PART OF THE CORRECTIVE ACTION ISSUED IN JULY 2010. THIS NEW TECHNIQUE WAS NOT FOLLOWED ON THE FIRST ATTEMPT TO IMPLANT THE STEM WHICH MAY ACCOUNT FOR THE STEM BECOMING LODGED IN THE CANAL. IN THE END, THE SURGEON CLOSELY FOLLOWED THE ALTERNATE TECHNIQUE WITH THE 17MM STEM AND THE 18MM REAMER WITH SUCCESS. HOWEVER, THE EXACT CAUSE CANNOT BE DETERMINED WITH CERTAINTY. EVAL: DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED UPON ATTEMPTING TO IMPLANT THE STEM, THE DEVICE SAT PROUD. THE SURGEON HAD TO REAM THE CANAL AGAIN IN ORDER TO GET THE DEVICE TO SEAT. THIS PROCESS RESULTED IN SURGERY TIME BEING EXTENDED BY 30 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER TRABECULAR METAL HUMERAL STEM SHOULDER PROSTHESIS HSD ZIMMER INC 60748335

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR