LEGION 71421385Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00885556029213), received between May 22, 2018 and May 30, 2024 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 30, 2024Migration; Migration

  IT WAS REPORTED THAT AFTER A FIRST TKA REVISION SURGERY PERFORMED IN 2014 AND A SECOND REVISION SURGERY PERFORMED ON (B)(6) 2020, THE PATIENT REPORTED A CONSIDERABLE PAIN IN HIS LEFT KNEE. A THIRD REVISION SURGERY WAS PERFORMED IN (B)(6) 2022, THE PATIENT CONTINUED EXPERIENCING CONSIDERABLE PAIN, HAVE A LOT OF STIFFNESS IN THE KNEE AND IS NOT ABLE TO BEND IT. IN (B)(6) 2023, THE SURGEON TOOK AN X-RAY THAT SHOWED NO PROBLEM WITH THE IMPLANT. ON (B)(6) 2024, ANOTHER X-RAY WAS TAKEN THAT SHOWED THE BOLT IN THE MIDDLE OF THE IMPLANT PROTRUDING OUTWARD TO THE LATERAL SIDE OF THE KNEE. ON (B)(6) 2024, ANOTHER X-RAY WAS TAKEN SHOWING THE BOLT PROTRUDING TO THE MEDIAL SIDE OF THE KNEE. IT APPEARS THAT THE CAP OR CAPS HAVE COME OFF THE BOLT AND IT IS SLIDING FREELY WITHIN THE IMPLANT. A NERVE BLOCK PROCEDURE WAS TRIED TO TREAT THE PAIN WITH NO SUCCESS. AT THE MOMENT, THE DOCTOR HAVE NO PLAN ON MOVING FORWARD.

  Patient problems: Failure of Implant; Loss of Range of Motion; Pain

  MAUDE report 19426373 ↗
• MalfunctionOct 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT, WHILE PERFORMING A TKA, DURING THE IMPLANTATION PROCEDURE, A SMALL METAL TAP CAME OFF FROM THE LEGION HK 11MM BOLT - SLEEVE UPON IMPACTION AND TIGHTENING WITH TORQUE WRENCH. THE PIECE WAS REMOVED FROM THE PATIENT. THE METAL TOOTH WAS VERY NARROW AND WAS DISPOSED OF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17914434 ↗
• InjuryOct 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING A REVISION SURGERY, BOTH LUGS OF 2 LEGION HK 11MM BOLT - SLEEVE BROKE OFF IN SITU. ON THE 1ST ATTEMPT AT SLEEVE PLACEMENT, THE SLEEVE WAS APPARENTLY CORRECTLY POSITIONED. THE BOLT SCREW COULD BE TIGHTENED WITH THE SCREWDRIVER. THE TORQUE WRENCH WAS THEN USED. THE BOLT SCREW COULD BE TURNED FREELY THROUGH 360°. THEN THERE WAS AN EXPLANTATION OF THE BOLT AND METAL SLEEVE. THE METAL PIN ON THE METAL SLEEVE WAS BROKEN OFF. ON THE SECOND ATTEMPT TO SET THE SLEEVE, THE SLEEVE WAS APPARENTLY CORRECTLY POSITIONED. THE BOLT SCREW COULD BE TIGHTENED WITH THE SCREWDRIVER. THE TORQUE WRENCH WAS THEN USED. THE BOLT SCREW COULD BE TURNED FREELY THROUGH 360°. THEN THERE WAS AN EXPLANTATION OF THE BOLT AND METAL SLEEVE. THE METAL PIN ON THE METAL SLEEVE WAS BROKEN OFF. FINALLY, ON THE THIRD ATTEMPT WITH THIRD NEW SLEEVE, THIS TIME THE TORQUE WAS DELIBERATELY OMITTED, BECAUSE IF IT HAD BEEN REPEATED AGAIN, THERE WOULD HAVE BEEN NO ALTERNATIVE. SURGERY WAS NOT DELAYED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12715086 ↗
• InjuryOct 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING A REVISION SURGERY, BOTH LUGS OF 2 LEGION HK 11MM BOLT - SLEEVE BROKE OFF IN SITU. ON THE 1ST ATTEMPT AT SLEEVE PLACEMENT, THE SLEEVE WAS APPARENTLY CORRECTLY POSITIONED. THE BOLT SCREW COULD BE TIGHTENED WITH THE SCREWDRIVER. THE TORQUE WRENCH WAS THEN USED. THE BOLT SCREW COULD BE TURNED FREELY THROUGH 360°. THEN THERE WAS AN EXPLANTATION OF THE BOLT AND METAL SLEEVE. THE METAL PIN ON THE METAL SLEEVE WAS BROKEN OFF. ON THE SECOND ATTEMPT TO SET THE SLEEVE, THE SLEEVE WAS APPARENTLY CORRECTLY POSITIONED. THE BOLT SCREW COULD BE TIGHTENED WITH THE SCREWDRIVER. THE TORQUE WRENCH WAS THEN USED. THE BOLT SCREW COULD BE TURNED FREELY THROUGH 360°. THEN THERE WAS AN EXPLANTATION OF THE BOLT AND METAL SLEEVE. THE METAL PIN ON THE METAL SLEEVE WAS BROKEN OFF. FINALLY, ON THE THIRD ATTEMPT WITH THIRD NEW SLEEVE, THIS TIME THE TORQUE WAS DELIBERATELY OMITTED, BECAUSE IF IT HAD BEEN REPEATED AGAIN, THERE WOULD HAVE BEEN NO ALTERNATIVE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12714943 ↗
• InjuryFeb 3, 2021Break; Break

  IT WAS REPORTED THAT AFTER PRIMARY TKR, THE PATIENT PRESENTED A PROSTHETIC JOINT INFECTION, AND UNDERWENT REVISION SURGERY TO PERFORM A WASHOUT AND A POLY EXCHANGE. THE LEGION HK 11MM BOLT WAS EXPLANTED THE DEVICE HAD BROKEN 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 11276759 ↗
• 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 9409686 ↗
• 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, SLEEVE WAS REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 9397892 ↗
• InjuryNov 15, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING A REVISION SURGERY (NOT CONFIRMED THAT THE REVISION SURGERY IS FROM SMITH AND NEPHEW), WHILE ASSEMBLING THE IMPLANTS, THE SCREW COULD NOT BE ATTACHED TO THE TIBIAL COMPONENT. AFTER MULTIPLE ATTEMPTS AND A DELAY OF 2 HOURS THE DOCTOR DECIDED TO CLOSE THE PATIENT TO AVOID ANY EXPOSURE TO MORE ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9331678 ↗
• InjuryFeb 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED SWELLING AND REDNESS IN THE RIGHT KNEE. THE CAUSE OF THE SWELLING AND REDNESS IS UNKNOWN. THE PATIENT WAS PRESCRIBED TO TAKE REST AND MEDICATION THERAPY.

  Patient problems: Swelling

  MAUDE report 8352799 ↗
• InjuryJan 31, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A SET SCREW BACKED OUT OF THE TIBIAL BASEPLATE BUT STAYED CONTAINED IN THE POLY.

  Patient problems: Injury

  MAUDE report 8295409 ↗
• InjuryNov 27, 2018Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A LEGION HK'S AXLE BREAK.

  Patient problems: Injury

  MAUDE report 8108151 ↗
• InjuryMay 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. ELEVEN DEVICES WERE REMOVED. PREVIOUS TO THIS REVISION SURGERY, A RIGHT KNEE WASHOUT AND A WOUND DEBRIMENT WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 7535266 ↗

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-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-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-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-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