BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN REVERSE HUMERAL STEM

    MDR report key: 1150087 · Received August 29, 2008

    Report

    Report Number
    1822565-2008-00563
    Event Type
    Malfunction
    Date Received
    August 29, 2008
    Report Date
    August 1, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE COULD NOT OBTAIN A COMPLETE CATALOG NUMBER; THEREFORE, A BASELINE REPORT CANNOT BE FILED. EVALUATION SUMMARY: THE NOMINAL FIT OF THE IMPLANT TO THE BONE PREPARATION IS INTENDED TO PROVIDE AN INTERFERENCE FIT CONDITION TO PROVIDE MECHANICAL STABILITY IN THE ABSENCE OF BONE CEMENT. DEPENDING ON PATIENT BONE QUALITY, AND THE AMOUNT OF BONE REMOVED, THE ELASTICITY OF THE REMAINING BONE MAY NOT ALLOW THE IMPLANT TO SEAT WITHIN NORMAL IMPACT FORCES IN SOME CASES. THIS WILL BE MONITORED VIA THE COMPLAINT PROCESS TO ENSURE THAT THE IMPLANT FIT RELATIONSHIP IS CONSISTENT. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION CODES: NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE, AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE SEATED ABOUT 2" PROUD. THE SURGEON EXTRACTED STEM, RE-REAMED DISTALLY WITH A LARGER SIZE DISTAL REAMER, SURGEON ALSO RE-REAMED WITH PROXIMAL REAMER, BUT REAMED IT THE MEDIAL EDGE OF THE CANAL OPENING. STEM SEATED APPROPRIATELY. THE SURGERY WAS DELAYED 30 MINUTES DUE TO THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK