LEGION 71423356Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556030271), received between Apr 17, 2017 and Oct 17, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2025Migration; Migration

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE SCREW COMPONENT OF THE POLY WAS BACKING OUT. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) LEGION HK GD MOTION ISRT 15MM SZ 4-5 LT WAS REMOVED BUT UNFORTUNATELY THE SCREW WAS BEHIND THE KNEE OF THE PATIENT AND IT WAS LEFT IMPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 23320056 ↗
• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2021, THE PATIENT SUSTAINED AN UNSPECIFIED INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO EXCHANGE THE LEGION HK GD MOTION ISRT 15MM SZ 4-5 LT AND LEGION HK 15MM BOLT - SLEEVE TO ADDRESS THIS COMPLICATION. THE I & D WAS DONE TO FIGHT OFF INFECTION. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17162139 ↗
• InjuryJun 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WILL BE PERFORMED DUE TO KNEE INSTABILITY.

  Patient problems: Injury

  MAUDE report 7603976 ↗
• InjuryJun 12, 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 JOINT INSTABILITY.

  Patient problems: Injury

  MAUDE report 7590256 ↗
• InjuryJul 27, 2017Detachment of Device or Device Component; Migration or Expulsion of Device; Malposition of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY TO REPLACE THE ARTICULAR INSERT OF TOTAL KNEE SYSTEM. DURING CHECK UP THE DOCTOR NOTICED THE INSERT SCREW OF THE HINGE INSERT WASN'T IN ITS ORIGINAL PLACE. BECAUSE OF PAIN, LAXITY AND UNCOMFORTED FEELING THE DOCTOR DECIDED TO REVISE THE INSERT OF THE LEGION HINGE.

  Patient problems: Discomfort; Failure of Implant; Pain

  MAUDE report 6746286 ↗
• InjuryApr 17, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED AN INFECTED HINGE WAS REVISED FOR WASHOUT AND DEBRIDEMENT, POLY CHANGE WAS DONE AS A PRECAUTION.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 6498064 ↗

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-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-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
• 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-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-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