BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER TRABECULAR METAL HUMERAL STEM

    MDR report key: 1840679 · Received September 17, 2010

    Report

    Report Number
    1822565-2010-00734
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    September 8, 2009
    Report Date
    September 10, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Removal / Correction Number
    1822565-7/26/2010-006-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: DURING TRABECULAR METAL HUMERAL AND THE TRABECULAR METAL REVERSE SHOULDER PROCEDURES, INSTRUMENTS PREPARE THE BONE FOR A TOLERANCE RANGE FROM SLIGHT PRESSFIT TO SLIGHT CLEARANCE. BECAUSE THESE STEMS HAVE PROXIMAL TRABECULAR METAL COMBINED WITH A PROXIMAL TAPER, THEY ACHIEVE ADEQUATE STABILITY THROUGH PROXIMAL FIXATION ALONE. IT HAS BEEN DETERMINED THAT DISTAL PRESS IS NOT REQUIRED AND THAT DISTAL PRESS COULD LEAD TO DIFFICULTY SEATING THE IMPLANT DEPENDANT ON BONE QUALITY, HUMERAL GEOMETRY, AND SURGEON REAMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE OCCURRENCE SUGGESTS THAT THE EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IS IMPLEMENTING CORRECTIVE ACTION. REFERENCE REMOVAL REPORT 1822565-7/26/2010-006-R FOR ADDITIONAL INFORMATION REGARDING THE CORRECTIVE ACTION TAKEN. AS RETURNED, THE STEM DOES NOT EXHIBIT ANY VISUAL FLAWS. DEVICE MEETS PRINT SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE RE-OPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT STEM DID NOT ADVANCE WITH MODERATE IMPACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER TRABECULAR METAL HUMERAL STEM SHOULDER PROSTHESIS HSD ZIMMER, INC. 61111852

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR