LEGION 71421905Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556108888), received between Nov 7, 2018 and Apr 26, 2021 — classified as 4 injuries.

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

7 other recalls cover devices cleared under the same FDA submission (K081111); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 26, 2021Unstable; Unstable

  IT WAS REPORTED THAT, DURING A TKA SURGERY THE LGN OFFSET COUPLER 4MM, LEGION HK TIBIAL BASE SZ 5 RIGHT AND LGN PRESSFIT STEM 14MM X 160MM BECAME UNSTABLE DURING FINAL STRETCHING. THE SURGERY WAS COMPLETED BY CHANGING THE IMPLANTS TO IMPLANTCAST. IT IS UNKNOWN IF SURGERY WAS DELAYED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11722574 ↗
• InjuryJun 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MEDICAL INTERVENTION WAS PERFORMED. PATIENT HAD RIGHT KNEE REPLACEMENT OF HINGE JOINT PUT IN. PATIENT HAS HAD SEVERE PAIN FOR OVER 13 MONTHS WITH CONTINUES INFLAMMATION, CONTINUED SEVERE KNEE PAIN, UNABLE TO BEND (10-40 DEGREES) OF THE KNEE WITHOUT SEVERE PAIN; CONTINUED DRAINING OF SYNOVIAL FLUID WITH RED BLOOD CELLS IN COLLECTION. MOST DRAINING CONSISTS OF REMOVING EXCESS OF 55 CC TO 70 CC.

  Patient problems: Pain

  MAUDE report 8723515 ↗
• InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INTERTROCHANTERIC LEFT HIP FRACTURE RESOLVED IN SURGICAL PROCEDURE. THE SURGEON CLAIMS THE HINGE SYSTEM TENDS TO BUCKLE WHICH MAY HAVE CAUSED THE FALL AND THE FEMORAL FRACTURE. BUCKLING IS FURTHER ATTRIBUTED TO LACK OF QUADRICEPS MUSCLE STRENGTH DUE TO LACK OF APPROPRIATE POST-OPERATIVE RECOVERY REGIMENT. ALSO, IT WAS STATED BY THE DOCTOR THAT S&N HINGE KNEE SYSTEM IS NOTED AS FUNCTIONING WELL AND REMAINS IMPLANTED.

  Patient problems: Injury

  MAUDE report 8256917 ↗
• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION WHICH INCLUDES REMOVING ALL IMPLANTS AND INSERTING AN ANTIBIOTIC SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 8046271 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081111. One submission often covers many models, so check the product and lot details in each record.

• Z-1105-2018 · Feb 1, 2018 · Terminated
  smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision Knee System Components are indicated for rheumatoid arthritis;
• Z-2091-2016 · May 26, 2016 · Terminated
  LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthri
• Z-2090-2016 · May 26, 2016 · Terminated
  LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthrit
• Z-2093-2016 · May 26, 2016 · Terminated
  LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthri
• Z-2095-2016 · May 26, 2016 · Terminated
  LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421365 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthriti
• Z-2094-2016 · May 26, 2016 · Terminated
  LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis
• Z-2092-2016 · May 26, 2016 · Terminated
  LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 71421374 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthrit