V40 FEMORAL HEAD WITH A 2.5 MM OFFSET.

Description of Event or Problem

A 63-YEAR-OLD FEMALE WAS BROUGHT TO THE OPERATING ROOM FOR A LEFT SIDED HEMIARTHROPLASTY UNDER GA. THE SURGEON THEN IMPLANTED THE STRYKER OMNIFIT SIZE 6, 120 MM EON C-TAPER STEM INTO THE FEMORAL CANAL. THE SURGEON THEN REQUESTED THE FEMORAL HEAD IMPLANT WITH A +2.5 MM OFFSET TO PLACE ON THE IMPLANTED STEM. THE VENDOR REPRESENTATIVE WHO BROUGHT THE IMPLANTS TO THE OPERATING ROOM GAVE THE SURGEON A V40 FEMORAL HEAD WITH A 2.5 MM OFFSET. THE SURGEON INSTALLED THE FEMORAL HEAD ON THE IMPLANTED STEM, TESTED THE SECURITY OF THE FIT AND PERFORMED A TRIAL REDUCTION AFTER APPLYING THE BIPOLAR HEAD. THE IMPLANTS WERE SECURE AND THERE WERE NO SIGNS OF INSTABILITY OF THE HIP DURING THE TRIAL REDUCTION. LATER THAT EVENING ((B)(6) 2024), INVESTIGATION REVEALED THAT THE STRYKER VENDOR (WHO WAS IN THE CASE) CONTACTED THE SURGEON AND NOTIFIED HIM THAT HE HAD GIVEN THE SURGEON A STRYKER V40 FEMORAL HEAD INSTEAD OF THE C-TAPER HEAD. THE V40 HEAD IS NOT COMPATIBLE WITH THE IMPLANTED STEM, AND ALTHOUGH CLINICALLY THERE SEEM TO BE A SECURE FIT, THE MORSE TAPER MISMATCH BETWEEN THE V40 AND C-TAPER HEADS COULD RESULT IN EARLIER FAILURE DUE TO FRETTING CORROSION AT THE MORSE TAPER CONNECTION. REVISION TO A C-TAPER HEAD TO MATCH THE STEM WAS DONE THE NEXT DAY. REVIEW OF THE TWO STRYKER "HEAD" IMPLANT BOXES (C-TAPER AND V40) INDICATE THAT THE BOXES WERE VIRTUALLY IDENTICAL (SAME COLOR/SIZE AND LETTERING). ONCE YOU REMOVE THE IMPLANTS FROM THE BOXES AND PLACE THEM SIDE BY SIDE, YOU CANNOT VISUALLY DISTINGUISH A C-TAPER HEAD FROM A V40 HEAD AS THEY ARE IDENTICAL ON THE SURFACE. THE BOX FOR THE STRYKER V40 (WHICH WAS IMPLANTED IN ERROR) INCLUDES THAT IT "SHOULD BE USED ONLY WITH V40 FEMORAL HIP STEMS", BUT THAT THE C-TAPER HEAD DOES NOT HAVE SIMILAR INFORMATION ON THE LABEL. WHILE THE VENDOR REPORTED THAT V40 SHOULD NOT HAVE FIT THE OMNIFIT FEMORAL STEM, IT DID IN THIS CASE AS CONFIRMED BY PHYSICAL MANEUVERS AND X-RAY CONFIRMATION AT THE END OF THE CASE. INVESTIGATION SHOULD BE DONE AS TO THE FEASIBILITY OF MODIFYING THE PACKAGE COLOR, COMPONENT DESCRIPTOR, OR OTHER OPTIONS TO VISUALLY ESTABLISH MATCHING COMPONENTS AS ONCE THE DEVICE IS REMOVED FROM THE BOX DETECTION OF AN ERROR IS IMPOSSIBLE.