LEGION 71421305Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556109137), received between Sep 22, 2017 and Jun 7, 2024 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Align” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT TKA WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED CONSIDERABLE PAIN IN HIS KNEE. DOCTOR SUSPECTED THAT THE LOWER (TIBIAL) PART OF THE SYSTEM WAS LOOSE. A REVISION SURGERY WAS PERFORMED IN (B)(6) 2022 TO ADDRESS THIS ADVERSE EVENT. WHEN THEY PERFORMED THE SURGERY THE IMPLANT WAS NOT LOOSE, BUT THE INSERT WAS REPLACED. PATIENT IS STILL SUFFERING FROM PAIN.

  Patient problems: Pain

  MAUDE report 19489899 ↗
• InjuryApr 17, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT, THE BOX AND STICKERS OF A LEGION HK TIBIAL BASE SZ 5 LT WERE INCORRECTLY LABELED AS LEFT BUT THE IMPLANT WAS RIGHT. THIS WAS DISCOVERED DURING TKA SURGERY AND AFTER BEING IMPLANTED TO THE PATIENT. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY WITH THE SAME DEVICE. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16752353 ↗
• InjuryMar 31, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2014, THE PATIENT EXPERIENCED INSTABILITY ON THE IMPLANTS. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022 TO EXPLANT THE WHOLE LEGION HK SYSTEM. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 13961341 ↗
• MalfunctionSep 16, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING TKR SURGERY, SURGEON WAS UNABLE TO ALIGN THE SCREW WITH THE LEGION HK GD MOTION ISRT 13MM SZ 4-5 LT AND THE LEGION HK TIBIAL BASE SZ 5 LT FOR A SUCCESSFUL INSERTION. SURGERY WAS RESUMED, AFTER A 40 MINUTES DELAY, WITH THE SAME DEVICES. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12485487 ↗
• InjuryFeb 28, 2020Adverse 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 IMPLANT LOOSENING. HINGE STRESS CAUSED THE FIXATION IMPLANTS TO BE LOOSE. PRIMARY SURGERY PERFORMED ON (B)(6) 2015.

  Patient problems: Injury

  MAUDE report 9770106 ↗
• InjuryDec 11, 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; Rupture

  MAUDE report 9451205 ↗
• 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 9445693 ↗
• InjurySep 22, 2017Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE LEGION HINGE HAS BROKEN. A REVISION SURGERY HAS BEEN SCHEDULED.

  Patient problems: Failure of Implant

  MAUDE report 6889003 ↗

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-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-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-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