LEGION 71421304Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556109144), received between Nov 22, 2017 and Nov 3, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 18, 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.

• InjuryNov 3, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT, AFTER A TKR WAS PERFORMED ON (B)(6) 2019, THE PATIENT PRESENTED IN THE LAST MONTHS OF THE YEAR 2021 AND EARLY 2022 A PROGRESSIVE MOBILIZATION OF THE IMPLANT, ACCOMPANIED BY PAIN AND MAINLY TIBIAL OSTEOLYSIS. THEREFORE ON (B)(6) 2022 THE PATIENT WAS SUBJECTED TO FURTHER SURGERY REVISION AND TOTAL REPLANTING OF THE PROSTHETIC IMPLANT, ASSOCIATED WITH MASSIVE BONE GRAFT IN THE PROXIMAL TIBIAL AREA (DURATION OF SURGERY 4 HOURS AND 39 MINUTES).

  Patient problems: Inadequate Osseointegration; Osteolysis; Pain

  MAUDE report 15721523 ↗
• InjuryApr 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION AND ALL PARTS WERE REMOVED. PATIENT RECEIVED ANTIBIOTIC SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 8497981 ↗
• InjuryApr 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION AND ALL PARTS WERE REMOVED. PATIENT RECEIVED ANTIBIOTIC SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 8497979 ↗
• InjuryApr 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION AND ALL PARTS WERE REMOVED. PATIENT RECEIVED ANTIBIOTIC SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 8497837 ↗
• InjuryNov 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT PRESENTED WITH AN INFECTION A WEEK AFTER HE UNDERWENT UNKNOWN PROCEDURE, WEEKS LATER ON (B)(6) HE WAS HOSPITALIZED DUE TO CELLULITIS ON LEFT ANTERIOR LEG.

  Patient problems: Cellulitis

  MAUDE report 7054737 ↗
• InjuryNov 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT PRESENTED WITH AN INFECTION A WEEK AFTER HE UNDERWENT UNKNOWN PROCEDURE, WEEKS LATER ON (B)(6), HE WAS HOSPITALIZED DUE TO CELLULITIS ON LEFT ANTERIOR LEG.

  Patient problems: Cellulitis

  MAUDE report 7054735 ↗
• InjuryNov 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT PRESENTED WITH AN INFECTION A WEEK AFTER HE UNDERWENT UNKNOWN PROCEDURE, WEEKS LATER IN (B)(6) HE WAS HOSPITALIZED DUE TO CELLULITIS ON LEFT ANTERIOR LEG.

  Patient problems: Cellulitis

  MAUDE report 7054525 ↗

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-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-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-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