BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM HUMERAL STEM

    MDR report key: 1243086 · Received November 21, 2008

    Report

    Report Number
    1822565-2008-00819
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 22, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE NOMINAL FIT OF THE IMPLANT TO THE BONE PREPARATION IS INTENDED TO PROVIDE AN INTERFACE FIT CONDITION TO PROVIDE MECHANICAL STABILITY IN THE ABSENCE OF THE BONE CEMENT. DEPENDING ON PATIENT BONE QUALITY AND THE AMOUNT OF THE BONE REMOVED, THE ELASTICITY OF THE REMAINING BONE MAY NOT ALLOW THE IMPLANT TO SEAT WITH THE NORMAL IMPACT FORCES IN SOME CASES. THIS WILL BE MONITORED VIA THE COMPLAINT PROCESS TO ENSURE THAT THE IMPLANT FIT RELATIONSHIP IS CONSISTENT. THE EXACT CAUSE CAN NOT BE DEFINITELY DETERMINED. 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 REPORTED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DOCTOR REAMED WITH THE STRAIGHT REAMER TO SIZE 12, AND IT WAS VERY TIGHT AT 12. PREPARED THE REST OF THE CANAL AS INSTRUCTED BY THE SURGICAL TECHNIQUE WITH BOTH TYPES OF PROXIMAL REAMERS. TRAILED WITH A 12/13 BODY AND A 12 X 130 DISTAL PILOT AND EVERYTHING WAS GREAT. WENT TO IMPLANT THE REAL STEM IMPLANT AND IT GOT STUCK IN THE CANAL APPROXIMATELY 2 TO 3 CM PROUD. THEY PULLED THE STEM SINCE IT WASN'T EVEN CLOSE TO BEING FULLY SEATED AND REPEATED OUR REAMING, AND CANAL PREPARATION STEPS ENSURING THAT THE INSTRUMENTS WERE THE PROPER SIZES AND DEPTHS. ON THE SECOND ATTEMPT, THE STEM DIDN'T FIT IN THE CANAL AND SO, THE DOCTOR DECIDED TO OPEN A SMALLER SIZE STEM AND IMPLANT THAT SINCE HE DIDN'T THINK THAT HE COULD REAM UP TO A 13. THE SURGEON DECIDED TO BONE GRAFT THE PROXIMAL CANAL WITH AUTOGRAFT FROM THE HUMERAL HEAD AND THEN IMPLANTED A SIZE 10 STEM WITH GOOD FIXATION AND STABILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK