Legion 71933073Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010593559), received between Nov 5, 2020 and Nov 5, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2020Break; Break

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, WHEN THE FLEXION SIZER ROD WAS INSERTED INTO THE FEMORAL CANAL, THE FIT WAS EXTREMELY TIGHT. WHEN IT WAS FULLY INSERTED, THE FEET OF THE GUIDE WERE NOT TOUCHING THE POSTERIOR CONDYLES. WHEN REMOVING THE GUIDE, THE ROD WAS INCARCERATED IN THE FEMORAL CANAL. SEVERAL ATTEMPTS WERE MADE TO GET A HOLD OF THE GUIDE WELL ENOUGH TO SLAP IT OUT OF THE CANAL. AFTER SEVERAL ATTEMPTS, THE ROD SNAPPED AT ITS INSERTION INTO THE GUIDE, LEAVING ONLY A THREAD OR TWO STICKING OUT OF THE BONE. ATTEMPTS TO GRAB THE ROD WERE UNSUCCESSFUL USING AVAILABLE INSTRUMENTS (PLIERS, RONGEURS, AND VICE GRIPS). EVENTUALLY, AFTER ATTEMPTING TO DIG IT OUT OF THE CANAL USING GOUGES, THE FEMUR FRACTURED AND THE ROD COULD BE RETRIEVED. THE ANTERIOR CORTEX OF THE FEMUR WAS FRACTURED NEAR THE TIP OF THE ROD. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER 30 MIN AND BACKUP FROM SMITH & NEPHEW WAS AVAILABLE TO FINISH THE SURGERY. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 10795537 ↗