LEGION 71423347Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556030868), received between Mar 4, 2025 and Mar 4, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A SECOND TKA REVISION SURGERY WAS PERFORMED IN 2016, THE PATIENT HAS BEEN COMPLAINING OF PAIN WITH A MECHANICAL BLOCKAGE SENSATION IN THE AREA OF THE LEFT KNEE JOINT FOR 2 MONTHS. UNTIL THEN, SHE HAD BEEN SATISFIED SINCE THE LAST OPERATION ON THE LEFT KNEE PROSTHESIS IN 2016. NO TRAUMA REMEMBERED. NO WRONG MOVEMENT REMEMBERED. THE PATIENT REPORTS THAT THERE ARE SOME BLOCKAGE PHENOMENA, BUT ALSO INSTABILITY IN THE LEFT KNEE JOINT. THE PATIENT REPORTS THAT SHE HAS BEEN WALKING ON A WALKER FOR A LONG TIME, IN THE LAST 2 MONTHS, HOWEVER, IT HAS BECOME SIGNIFICANTLY WORSE. NOW THE X-RAY AND CT SHOW THE SCREW LOOSENING OF THE POSTERIOR INLAY SCREW AGAIN. A REVISION SURGERY IS SCHEDULED FOR AN UNSPECIFIED DATE, IN WHICH AN SCREW THREAD INSPECTION WILL BE PERFORMED. IF IT IS INTACT A REPLACEMENT OF MOBILE PARTS (COUPLING MECHANISM, INLAY, SCREW) WILL BE PERFORMED, BUT IF IT IS DAMAGED A REPLACEMENT OF THE TIBIAL COMPONENT WILL TAKE PLACE.

  Patient problems: Failure of Implant; Joint locking; Pain

  MAUDE report 21518082 ↗

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-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-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
• 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-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