LEGION 71423358Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556030813), received between Dec 10, 2019 and Jan 26, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2024Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT TKA REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, THE LEGION HINGE CONSTRUCT BECAME UNSTABLE AFTER A FEW MONTHS OF BEING IMPLANTED. SURGEON SUSPECTS THAT THE LEGION HK GD MOTION ISRT 18MM SZ 4-5 LT WAS UNDERSIZED AND POSITIONED LOOSE, AS THE THICKNESS OF THE POLY WAS UPSIZED DURING THE SECOND REVISION PERFORMED ON (B)(6) 2023 AND THE CONSTRUCT WAS VERY STABLE AFTER IMPLANTATION. PATIENT IS DOING WELL WITH THE REVISED IMPLANTS.

  Patient problems: Joint Laxity

  MAUDE report 18591346 ↗
• InjuryJan 26, 2024Unstable; Unstable

  IT WAS REPORTED THAT, AFTER A LEFT TKA HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UNSTABLE INTERNAL HINGE COMPONENTS DUE TO A LARGE VARUS/VALGUS THRUST. A FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THIS ADVERSE EVENT, IN WHICH ONE (1) LEGION HK GD MOTION ISRT 18MM SZ 4-5 LT, ONE (1) LEGION HK 18MM BOLT ¿ SLEEVE, ONE (1) LGN HK AXLE SZ 5 FEMUR, ONE (1) LGN HK LINK ASSY SZ 2-5 FEM, ONE (1) LEGION HINGE AXLE PLUG AND ONE (1) LEGION HINGE HYPEREXTENSION STOP WITH AXLE PLUGS WERE EXPLANTED.

  Patient problems: Joint Laxity

  MAUDE report 18591186 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY, A LEGION HK GD MOTION ISRT 18MM SZ 4-5 LT SWAP OF A HINGE KNEE IN WHICH WAS SOME PAIN AND INFECTION PRESENT. UPON VISUAL OF X-RAY, IT WAS NOTICED THAT THE LEGION PATELLA HAD SHEARED OFF AT THE PEGS, AND THE SET SCREW WAS NOT THREADED INTO THE BASEPLATE, IT WAS ¿FLOATING¿ IN THE POLY AS THOUGH IT HAD NOT BEEN SCREWED INTO THE BASEPLATE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2023, IN WHICH FEMUR WAS OPENED UP, POLY REPLACED WITH A 13MM, AND THE PATELLA TRACKED WELL AND AS SUCH WAS NOT REPLACED. CURRENT HEALTH STATUS OF PATIENT IS DOING WELL POST-OPERATIVE.

  Patient problems: Failure of Implant; Pain; Unspecified Infection

  MAUDE report 17730537 ↗
• InjuryAug 23, 2022Labelling, Instructions for Use or Training Problem; Improper or Incorrect Procedure or Method; Labelling, Instructions for Use or Training Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AFTER A RIGHT TKA SURGERY PERFORMED ON (B)(6) 2022 IT WAS NOTICED THAT THE WRONG SIDED INSERT HAD BEEN IMPLANTED IN TO THE PATIENT (LEGION HK GD MOTION ISRT 18MM SZ 4-5 LT). THE SURGEON WAS INFORMED IMMEDIATELY. A REVISION SURGERY WAS MADE ON (B)(6) TO CORRECT THIS ISSUE. DURING THE INITIAL SURGERY ALL IMPLANTS WERE PRESENTED TO THE SURGEON AND THE SCRUB NURSE FOR APPROVAL. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15274584 ↗
• InjuryApr 9, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN LOCKING THE LEGION HK GD MOTION ISRT 18MM SZ 4-5 LT ON THE POSTERIOR, SCREW BROKE IN HALF AND THE BOTTOM HALF GOT STUCK IN THE BASEPLATE. SURGERY WAS FINISHED, AFTER A DELAY OF 30 MINUTES OR LESS AND WITH A CHANGE IN THE SURGICAL TECHNIQUE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14068479 ↗
• InjuryDec 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD RUPTURE OF LEFT QUAD TENDON POSTOPERATIVE. AN UNSPECIFIED SURGERY WAS PERFORMED TO REMEDIATE IT.

  Patient problems: Injury

  MAUDE report 9448923 ↗
• InjuryDec 10, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT EXTENSOR MECHANISM RECONSTRUCTION SURGERY WAS PERFORMED POSTOPERATIVE.

  Patient problems: Injury

  MAUDE report 9445504 ↗

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-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-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