LEGION 71423341Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556031087), received between Dec 2, 2019 and Nov 29, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Expulsion” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 29, 2022Expulsion; Expulsion

  IT WAS REPORTED THAT, AFTER A PROCEDURE WAS PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED MIGRATION OF THE SCREW. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH A LEGION HK GD MOTION ISRT 11MM SZ 2-3 LT WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 15882633 ↗
• InjuryMar 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER PRIMARY TKR, THE PATIENT PRESENTED A PROSTHETIC JOINT INFECTION, AND UNDERWENT TO A REVISION SURGERY TO PERFORM A WASHOUT AND A POLY EXCHANGE. THE LEGION HK GD MOTION INSERT 11MM SZ 2-3 LEFT (B)(4) WAS EXPLANTED, AS WELL AS THE LEGION HK 11MM BOLT - SLEEVE (B)(4) SINCE IT WAS REPORTED THAT THE SLEEVE OF THE HINGE PROSTHESIS WHICH HOLDS THE BOLT ANTI-ROTATIONAL PART BROKE OFF, CAUSING THE SLEEVE TO ROTATE. THE PATIENT IS CURRENTLY MOBILIZING ADEQUATELY ASYMPTOMATIC. ADDITIONAL DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 11478925 ↗
• InjuryDec 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY OF LEGION HINGE POLY AND LOCKING BOLT WAS PERFORMED DUE TO AN INFECTION. NO OPERATIVE REPORTS ARE AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 9409873 ↗
• InjuryDec 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT SECOND REVISION SURGERY WAS PERFORMED DUE TO INFECTION, INSERT WAS REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 9397811 ↗
• InjuryDec 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER PRIMARY HINGE A REVISION SURGERY WAS PERFORMED AND THE POLY WAS EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 9395111 ↗

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-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-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