BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN TRABECULAR METAL REVERSE STEM

    MDR report key: 1881025 · Received October 6, 2010

    Report

    Report Number
    1822565-2010-00851
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    April 1, 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
    CO, 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 PRESS FIT 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 INFO 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 INFO REGARDING THE CORRECTIVE ACTION TAKEN. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE ITEM AND LOT NUMBER ARE UNKNOWN. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING IMPLANTATION, THE IMPLANT WAS SITTING PROUD BY 1CM. A 30 TO 45 MINUTE TIME DELAY WAS ALSO REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1