LEGION 71453101Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556033432), received between Jul 19, 2018 and Apr 15, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2025Material Erosion; Material Deformation; Material Erosion; Material Deformation

  IT WAS REPORTED THAT, AFTER A B/L TKR PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED POSTEROMEDIAL SWELLING IN HER LEFT KNEE ON (B)(6) 2023, WHICH GRADUALLY PROGRESSED. ON (B)(6) 2024, THE PATIENT DEVELOPED LEFT-SIDED FOOT DROP. IT WAS FOUND THAT THE PATIENT HAD AN EXTENSIVE IMPLANT WEAR WITH EXTENSIVE FOREIGN BODY REACTION (WEAR PARTICLE) IN THE FORM OF MULTI-LOCULATED CYSTS IN THE POSTEROMEDIAL AND POSTERIOR PART OF THE KNEE CROSSING THE MIDLINE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2025 IN WHICH ONE (1) UNKN LEGION TOTAL KNEE PRIM TIB INSERT XLPE, ONE (1) OXINIUM LEGION CR FEMUR, SZ 0 LT AND ONE (1) UNKN LEGION TOTAL KNEE PRIM TIB BASEPLATE WERE EXPLANTED, FOLLOWED BY POPLITEAL CYST(S) EXCISION AND PERINEAL NERVE DECOMPRESSION ON (B)(6) 2025. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Impingement; Metal Related Pathology; Nerve Damage; Unequal Limb Length

  MAUDE report 21845610 ↗
• InjuryJul 2, 2024Degraded; Degraded

  IT WAS REPORTED THAT, AFTER A BILATERAL TKA SURGERY WAS PERFORMED ON (B)(6) 2019, THE PATIENT EXHIBITED LEFT KNEE INSTABILITY, IMPLANT LOOSENING, POLY SPACE WEAR, FEMORAL COMPONENT DAMAGE AND FEMORAL COMPONENT DEBRIS (SUGGESTIVE OF POSSIBLE METALLOSIS). AFTER X-RAYS WERE TAKEN ON (B)(6) 2023, THE PATIENT WAS ADVISED TO PERFORM WEIGHT MANAGEMENT STRATEGIES SUCH AS DIETARY ADJUSTMENTS, STATIC CYCLING AND SUPPORTIVE FOOTWEAR. FURTHER X-RAYS TAKEN ON (B)(6) 2024, REVEALED INDICATIONS OF IMPLANT WEAR, CALCIFICATION, AND METALLOSIS IN THE LEFT KNEE. IT WAS STATED ON A PET-CT REPORT DATED (B)(6) 2024 THAT THE BILATERAL TKR STATUS WAS NOTED WITH SIGNIFICANT STREAK ARTEFACTS AROUND IT OBSCURING THE LOCOREGIONAL ANATOMIC DETAILS, WITH DIFFUSE INCREASED FDG UPTAKE AROUND THE LEFT KNEE JOINT. IT IS UNKNOWN HOW THIS ADVERSE EVENT WILL BE TREATED. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 19656772 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA PERFORMED ON AN UNKNOWN DATE. A REVISION SURGERY WAS PERFORMED TO TREAT THE ADVERSE EVENT. THE LGN CR HIGH FLEX XLPE SZ 1-2 9MM WAS CRACKED. SUBSEQUENTLY THE GII CM TIB SIZE 2 {} RIGHT WAS EXTRACTED. THE LOCKING MECHANISM OF GII CM TIB SIZE 2 {} RIGHT IS JEOPARDIZED. FURTHER INFORMATION IS UNKNOWN AT THE MOMENT.

  Patient problems: Failure of Implant

  MAUDE report 15204140 ↗
• InjuryApr 29, 2019Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE POSTERIOR PART OF THE POLY BROKE OFF AND STARTED RUBBING AGAINST TIBIA BASE PLATE. NO MORE INFORMATION REPORTED YET.

  Patient problems: Injury

  MAUDE report 8563325 ↗
• InjuryFeb 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. INSERT WAS EXCHANGED TO NEW INSERT. OTHER IMPLANTS WERE RETAINED. NO ADDITIONAL INJURIES REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 8370622 ↗
• InjuryOct 3, 2018Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SEVERE WEAR AND METAL DEBRIS NOTED ON X-RAYS.

  Patient problems: Injury

  MAUDE report 7931222 ↗
• InjuryOct 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED. MEDIAL PATELLOFEMORAL LIGAMENT RECONSTRUCTION WITH SEMITENDINOSUS ALLOGRAFT LEFT KNEE AND APPLICATION OF LONG LEG IMMOBILIZER. NO IMPLANTS REMOVED.

  Patient problems: Injury

  MAUDE report 7924588 ↗
• InjuryOct 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.

  Patient problems: Injury

  MAUDE report 7922747 ↗
• InjuryJul 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AT TIME OF PRIMARY SURGERY THE PATIENT WENT TO GREAT LENGTHS VIA DIET AND MEDICATION TO GAIN CONTROL OVER DIABETES. SINCE THIS TIME THE PATIENT HAS REGRESSED TO NOW BE A POORLY CONTROLLED DIABETIC. THE PATIENT HAS HAD RECURRENT CHEST INFECTIONS TREATED WITH ANTIBIOTICS. RECENTLY DEVELOPED SYMPTOMS OF INFECTED KNEE. ALL IMPLANTS WERE REMOVED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7703763 ↗

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-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-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-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
• 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