LEGION 71453111Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00885556033975), received between Nov 2, 2017 and Nov 6, 2024 — classified as 17 injuries, 2 malfunctions.

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

6 other recalls cover devices cleared under the same FDA submission (K071071, K230653); 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2024Degraded; Degraded

  IT WAS REPORTED THAT, AFTER A TKA SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED PAIN. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH ONE (1) LGN CR HIGH FLEX XLPE SZ 3-4 9MM WAS EXCHANGED. THE SURGEON NOTICED THAT THE POLY LOOKED WORN. THE PATIENT LEFT SURGERY IN GOOD HEALTH.

  Patient problems: Pain

  MAUDE report 20616298 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON AN UNDISCLOSED DATE, THE PATIENT EXPERIENCED INFECTION. THIS ADVERSE EVENT WAS TREATED BY A WASHOUT AND REVISION SURGERY ON (B)(6) 2023, IN WHICH A LGN CR HIGH FLEX XLPE SZ 3-4 9MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 17822113 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKR SURGERY WAS PERFORMED ON (B)(6) 2021 USING A LGN CR HIGH FLEX XLPE SZ 3-4 9MM DEVICE, THE PATIENT REPORTED AN INFECTION. DUE TO THIS, A REVISION SURGERY WAS PERFORMED IN ORDER TO REPLACE THE DEVICE. NO FURTHER PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 15789256 ↗
• InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKR SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT DESCRIPTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON AN UNKNOWN DATE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 12331823 ↗
• MalfunctionJun 22, 2021Connection Problem; Material Twisted/Bent; Connection Problem; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A TKA, THE MEDIAL DOVETAIL MECHANISM WAS BENT ON THE DISTAL PORTION OF LGN CR HIGH FLEX XLPE SZ 3-4 9MM WAS BENT CAUSING AN OBSTRUCTION. THE DEVICE DID NOT SEAT OR LOCK INTO PLACE. PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, BY USING A BACK-UP DEVICE. PATIENT WAS NOT IMPACTED BY THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046566 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO SUSPICIOUS OF PATELLA LOOSENING, OVERSIZING. DURING THE REVISION SURGERY, NO ISSUE WAS FOUND WITH THE PATELLA, BUT THE INSERT WAS CHANGED DUE TO LOOSENING AND OVERSIZING. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805757 ↗
• InjuryMar 22, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT AFTER TKA PRIMARY SURGERY, PATIENT PRESENTED WITH EXCESSIVE POSTERIOLATERAL WEAR ON HIS LEGION CRUCIATE RETAINING HIGH FLEXION HIGHLY CROSS LINKED POLYETHYLENE, LEADING TO OXINIUM FEMORAL COMPONENT ARTICULATING ON TITANIUM BASEPLATE. A REVISION SURGERY WAS PERFORMED DUE TO THIS EVENT FOR EXPLANTATION OF THE POLY. THE OUTCOME OF THE PATIENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 11539999 ↗
• MalfunctionMar 8, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A TKA THE LGN CR HIGH FLEX XLPE SZ 3-4 9MM DID NOT LOCK INTO TIBIA BASE. INSTRUMENTS OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH-NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431774 ↗
• InjuryDec 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY OF LEGION PRIMARY CR PROSTHESIS WAS PERFORMED DUE TO MALROTATION FEMUR. THE LEGION CR HIGH FLEX XLPE SZ 3-4 9MM WAS REVISED AND EXCHANGED. THE PATIENT WAS DISCHARGED FROM HOSPITAL.

  Patient problems: Failure of Implant

  MAUDE report 11001985 ↗
• InjuryOct 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD S+N SINCE 2019. THE PATIENT FELL AND RUPTURED HIS PATELLA TENDON. THE PATELLA IMPLANT WAS REMOVED AND THE PATELLA TENDON WITH ALLOGRAFT WAS PERFORMED. THE LINER WAS EXCHANGE TO A DISHED INSERT FOR ADDITIONAL STABILITY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Rupture

  MAUDE report 10744077 ↗
• InjuryFeb 18, 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 TO REVISE THE INSERT ON (B)(6) 2020 DUE TO PAIN. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2015.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9720208 ↗
• InjuryJan 13, 2020Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY FROM A CR INSET TO A DISHED INSERT. SAME THICKNESS WAS USED.

  Patient problems: Injury

  MAUDE report 9580077 ↗
• InjuryDec 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN. THE SURGEON STATED THAT IT COULD BE RELATED TO EITHER PAIN OR AN ALLERGIC REACTION. ADDITIONALLY, REPORTS OF THE IMPLANTS ARE NOT NECESSARY AND THEY ARE NOT AVAILABLE FOR EVALUATION. DEVICES WILL BE EXCHANGED FOR CEMENT MOLDS.

  Patient problems: Pain

  MAUDE report 9510831 ↗
• InjuryOct 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION AND A FEELING OF WRONGNESS. THREE PARTS WERE REMOVED: LEGION OX FEMORAL COMPONENT, LEGION BASE PLATE, LEGION INSERT. THESE COMPONENTS WERE REPLACED WITH: LEGION OX FEMORAL COMPONENT AND LEGION INSERT. PRE-EXISTING CONDITIONS: OSTEOARTHRITIS.

  Patient problems: Injury

  MAUDE report 9187435 ↗
• InjuryAug 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED, IT IS UNKNOWN THE REASON FOR THIS REVISION.

  Patient problems: Injury

  MAUDE report 8862839 ↗
• InjuryJun 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED ARTHROFIBROSIS IN THE LEFT KNEE. PATIENT WAS TREATED WITH A MANIPULATION UNDER ANESTHESIA. THE EVENT WAS RESOLVED.

  Patient problems: Fibrosis

  MAUDE report 8663517 ↗
• InjurySep 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON KNEE TO REPLACE THE INSERT DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7908161 ↗
• InjurySep 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A KNEE REVISION SURGERY WAS PERFORMED TO ONE SIDE OF BILATERAL PATIENT DUE TO INFECTION. IT IS UNKNOWN WHICH SIDE WAS AFFECTED.

  Patient problems: Injury

  MAUDE report 7900162 ↗
• InjuryNov 2, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT HAS UNDERGONE MULTIPLE MANIPULATIONS UNDER ANESTHESIA DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 6997824 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071071, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-2621-2023 · Aug 31, 2023 · Open, Classified
  smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
• Z-1507-2020 · Dec 19, 2019 · Terminated
  LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
• Z-1907-2018 · Mar 30, 2018 · Terminated
  smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF 71453101designed for use in patients in primary and revision surgery, where the anterior and poster
• Z-1904-2018 · Mar 30, 2018 · Terminated
  smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revision surgery, where the anterior and post
• Z-1905-2018 · Mar 30, 2018 · Terminated
  smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF 71453122 designed for use in patients in primary and revision surgery, where the anterior and post
• Z-1906-2018 · Mar 30, 2018 · Terminated
  smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and revision surgery, where the anterior and poste