Z1¿ HIP SYSTEM

Description of Event or Problem

THIS OCCURRED DURING OUR ROUTINE PRIMARY THA [TOTAL HIP ARTHROPLASTY]. THE FEMORAL STEM WAS INSERTED USING THE FEMORAL STEM INSERTER AND A MALLET. THE PIECE SEEMS TO HAVE BROKEN OFF AT THAT TIME; HOWEVER, IT WAS NOT REALIZED DURING THE CASE NOR IN THE POST-OP X-RAY. DURING THE ROUTINE POST-OP CHECK-UP IN THE SURGEON'S CLINIC, THE X-RAY REVEALED THE UNIDENTIFIED METAL PIECE RIGHT BY THA. UPON EXAMINATION, WE FOUND THE FEMORAL STEM INSERTER WITH A MISSING PIECE. FURTHER INSPECTION REVEALED 2 OUT OF OUR 3 INSERTERS WERE MISSING THE PIECE, INDICATING ANOTHER BREAKAGE. IT WAS DECIDED THAT REMOVING IT WOULD CAUSE MORE HARM THAN BENEFITS. THE PATIENT IS NOT SYMPTOMATIC, AND IT WAS DECIDED TO LEAVE IT IN PLACE FOR NOW. THE WHOLE EVENT WAS ESCALATED AND COMMUNICATED TO THE PATIENT BY THE ATTENDING SURGEON. THIS IS A FEMORAL STEM INSERTER, AND IT WAS USED WITH A MALLET. POUNDING THE INSERT MAY CONTRIBUTE TO THE BREAKAGE; HOWEVER, IT SHOULD WITHSTAND SUCH IMPACTS. THE INSERTER'S CONSTRUCTION IS POOR, AS IT IS NOT BUILT WITH A SOLID ONE-PIECE, CAUSING IT TO BREAK WHERE IT IS SOLDERED. MANUFACTURER RESPONSE FOR FEMORAL STEM INSERTER, (BRAND NOT PROVIDED) (PER SITE REPORTER). THEY ARE ESCALATING THE ISSUE TO THEIR CORPORATE OFFICE.