Description of Event or Problem · 1
A WOMAN WITH HISTORY OF SEVERE DEGENERATIVE JOINT DISEASE, FOR ELECTIVE TOTAL HIP REPLACEMENT. DURING OPERATIVE PROCEDURE, THE SMITH AND NEPHEW FEMORAL HEAD SIZER WAS USED TO DETERMINE THE APPROPRIATE SIZE OF THE PROSTHESIS, THE BALL ON THE END OF THE FEMORAL SIZER BECAME DISENGAGED AND WAS NOT RETRIEVABLE FROM THE OPERATIVE SITE. THE SIZING DEVICE CONSISTS OF 3 PIECES, WITH THE BALL ON THE SIZING DEVICE BEING EASILY REMOVABLE TO ALLOW FOR SIZING. THE BALL ADHERES TO THE NECK OF THE SIZING DEVICE WITH THE ASSISTANCE OF THE RETAINING "O" RING INSIDE THE BALL. THE "O" RING CAN SUFFER FROM WEAR AND TEAR AND LESSEN THE ADHERENCE TO THE SIZING DEVICE OVER TIME. THE QI PROCESS BY THE VENDOR, TO ENSURE THE "O" RING IS NOT WORN, IS UNCLEAR. THE VENDOR REP DOES NOT INSPECT THE "O" RING OR ASSESS THE DEGREE OF ADHERENCE OF THE BALL TO THE DEVICE PRIOR TO BEGINNING THE CASE. THE VENDOR DOES NOT TRACK THE LIFE OR NUMBER OF CASES IN WHICH THESE SIZING DEVICES ARE USED. IT IS NOT UNCOMMON TO HAVE THE BALL ON THE SIZER POP OFF DURING RANGE OF MOTION TO ASSESS APPROPRIATE SIZE. IT IS UNCOMMON FOR THE BALL TO BECOME DISLODGED AND IRRETRIEVABLE WITHIN THE INCISION. FEMORAL HEAD SIZER IS NOT RADIOPAQUE AND WAS NOT RETRIEVABLE FROM THE SOFT TISSUE AROUND THE HIP JOINT, SO THE HIP REPLACEMENT WAS COMPLETED AND THE OPERATIVE SITE CLOSED. THE PT UNDERWENT AN MRI 2 MONTHS LATER, THE SIZER BALL WAS LOCATED AND THE PT RETURNED TO THE OR FOR RETRIEVAL WHICH WAS UNEVENTFUL. DIAGNOSIS OR REASON FOR USE: TO SIZE THE HIP JOINT FOR THE PROSTHESIS.