LEGION 71423353Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556108703), received between Aug 15, 2017 and Feb 5, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A SET SCREW BACKED OUT OF THE TIBIAL BASEPLATE BUT STAYED CONTAINED IN THE POLY.

  Patient problems: Injury

  MAUDE report 8307639 ↗
• 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 8256863 ↗
• InjuryAug 15, 2017Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO EXCHANGE A RIGHT KNEE INSERT THAT WAS IMPLANTED INTO THE LEFT KNEE.

  Patient problems: Injury

  MAUDE report 6795208 ↗

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-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
• 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-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-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-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-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