LEGION 71421807Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010545411), received between Feb 5, 2020 and Mar 1, 2021 — classified as 1 injury, 2 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K041106, K230653); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING USE, OUTSIDE THE PATIENT, THE SCREW OF THE POSTERIOR WEDGE COULD NOT FULLY ENGAGE WITH THE LEGION OXINIUM FEMUR SCREW HOLE. BECAUSE OF THIS THE POSTERIOR WEDGE COULD NOT BE PROPERLY TIGHTENED AND WOULD STAY A BIT LOOSE. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. SURGICAL DELAY LESS THAN 30 MINUTES. PATIENT INJURIES WERE NOT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391136 ↗
• InjuryFeb 23, 2021Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT, DURING THE SET UP FOR A TKA PROCEDURE, WHEN THE SURGEON WAS SCREWING A SIZE 7-8 5MM POSTERIOR FEMORAL WEDGE ON THE MEDIAL SIDE OF A SIZE 7 LEGION CONSTRAINED FEMORAL COMPONENT THE WEDGE WOULD NOT SEAT. SURGEON USED ANOTHER SCREW FOR A 5MM POSTERIOR FEMORAL WEDGE AND IT STILL DID NOT SEAT. THE SURGEON TRIED THE WEDGE ON THE LATERAL SIDE AND IT DID SEAT. PROCEDURE WAS FINISHED WITH THE SAME DEVICE, BUT THE SURGEON DID NOT USE THE WEDGE AS PLANNED FOR THE MEDIAL SIDE AND IMPLANTED THE FEMORAL COMPONENT WITHOUT IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11366398 ↗
• MalfunctionFeb 5, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING SURGERY, THE POST WEDGE WOULD NOT SCREW TIGHT ENOUGH ON THE FEMUR. SURGEON HAD TO CEMENT WEDGE INTO PLACE. NO DELAY TO PROCEDURE, NO INJURY TO PATIENT. BACKUP S&N DEVICE WAS AVAILABLE BUT NOT USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9671176 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041106, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-2621-2023 · Aug 31, 2023 · Open, Classified
  smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
• Z-0092-2018 · Sep 14, 2017 · Terminated
  smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are indicated for rheumatoid