BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZMR HIP SYSTEM FEMORAL STEM REVISION TAPER WITH COMPRESSION NUT

    MDR report key: 1449230 · Received June 5, 2009

    Report

    Report Number
    1822565-2009-00631
    Event Type
    Malfunction
    Date Received
    June 5, 2009
    Date of Event
    April 15, 2009
    Report Date
    April 29, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION SUMMARY: THE COMPLAINT ALLEGES THAT A 22X185MM ZMR TAPER STEM IMPLANTED SEATED PROUD FROM THE REAMED DEPTH. THE SURGEON USED THE ZMR CROSSOVER DISTAL REAMERS TO PREPARE THE FEMUR FOR THE DISTAL IMPLANT. UPON INITIAL REAMING, THE 22 MM TAPER STEM SEATED APPROXIMATELY 2" PROUD. THE FEMUR WAS SUBSEQUENTLY RE-REAMED DEEPER TWICE, WITH THE STEM SEATING TO THE PROPER LOCATION AFTER THE THIRD REAMING. THE STEM WAS REMOVED LATER DURING SURGERY DUE TO INSTABILITY AND REPLACED WITH A 23MM ZMR XL STEM. THE INSTRUMENTS USED IN SURGERY WERE NOT RETURNED FOR REVIEW. POTENTIAL CAUSES FOR THE STEM SEATING PROUD INCLUDE, BUT ARE NOT LIMITED TO, REAMING TO THE INCORRECT REAMER DEPTH INDICATORS OR USING THE INCORRECT SIZE REAMER. THE IMPLANT WAS FOUND TO BE UNSTABLE LIKELY DUE TO THE MULTIPLE REAMING STEPS WITH THE REAMER BEING REMOVED EACH TIME. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE CAUSE CAN NOT BE DETERMINED WITH CERTAINTY. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING SURGERY ON (B) (6) 2009, THE SURGEON ELECTED TO IMPLANT 22X185MM ZMR TAPER STEM AFTER ACHIEVING SATISFACTORY FIT OF REAMER AND CONFIRMATION OF FIT WITH FLUOROSCOPY. UPON IMPACTION OF THE 22MM IMPLANT, THE STEM WOULD NOT FULLY SEAT TO APPROPRIATE DEPTH IN THE FEMORAL CANAL; AFTER REAMING FEMORAL CANAL DEEPER WITH 22 TAPER REAMER. UPON SECOND IMPACTION THE 22MM STEM WOULD NOT FULLY SEAT. SURGEON ELECTED TO USE THE NEXT SIZE SMALLER TAPER STEM (20MM) BUT THIS IMPLANT DID NOT GIVE SATISFACTORY PRESS-FIT. SURGEON AGAIN REAMED WITH THE 22MM REAMER TO ATTEMPT TO OPEN CANAL ENOUGH FOR 22MM STEM TO SEAT. STEM SEATED TO APPROPRIATE DEPTH AND HE PREPARED PROXIMAL FEMUR USING OTJ TECHNIQUE AND REAMERS. AFTER TRIALING THE PROXIMAL BODY SURGEON REQUESTED A 46X35MM CONE BODY. BEFORE IMPLANTING THE PROXIMAL BODY, THE SURGEON ONCE AGAIN CHECKED THE STABILITY OF THE DISTAL TAPER STEM. UPON FINAL INSPECTION OF THE DISTAL STEM STABILITY, HE WAS NOT SATISFIED WITH THE PRESS FIT. AT THIS POINT, HE SWITCHED TO THE ZMR XL TAPER 23MM STEM WHICH SEATED AND GAVE A SATISFACTORY PRESS FIT. TRIALED AND IMPLANTED A 46X78 ZMR XL BODY. SURGERY WAS DELAYED 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZMR HIP SYSTEM FEMORAL STEM REVISION TAPER WITH COMPRESSION NUT HIP PROSTHESIS KWY ZIMMER, INC. NA 60707631

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR