Legion 71442011Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00885556537152), received between Oct 16, 2017 and Jun 13, 2023 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

2 other recalls cover devices cleared under the same FDA submission (K162775); 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, THE SCREW ON THE BACK OF THE GOLD SECTION OF A LEGION CONE IMPACTOR HANDLE POPPED OUT AS IT WAS ON THE BACK TABLE, WHILE LOADING UP A BROACH. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17117610 ↗
• MalfunctionMay 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, ONE (1) LGN CONE IMPACTOR HANDLE BROKE OFF WHILE IMPACTING BROACH IN THE ALIGNMENT COLLAR SECTION. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16976990 ↗
• MalfunctionOct 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING INSPECTION, THE TIP OF THE CONE BROACH HANDLE OF A LGN CONE IMPACTOR HANDLE WAS BROKEN OFF. IT WASN¿T ABLE TO CORRECTLY ATTACH CONE BROACHES. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE INSTEAD. SINCE THIS HAPPENED BEFORE PROCEDURE, PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544242 ↗
• MalfunctionMar 22, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A LEGION CONE IMPACTOR HANDLE BROKE AND IS IN MULTIPLE PIECES. IT IS UNKNOWN IF ANY PIECES FELL INSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13848078 ↗
• InjuryFeb 17, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE TIP OF THE HANDLE OF A LGN CONE IMPACTOR HANDLE CHIPPED OFF AND FELL INTO THE TIBIAL CANAL. FROM POSTOPERATIVE X-RAYS PROVIDED, THE BROKEN PIECE APPEARS TO BE LEFT INSIDE THE PATIENT'S LIMB. NO SURGICAL DELAY WAS REPORTED TO OCCUR DUE TO THIS INCIDENT. FURTHER DETAILS CONCERNING THE PATIENT'S HEALTH STATUS OR ANY ADDITIONAL INTERVENTION REQUIRED ARE UNKNOWN AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 13552497 ↗
• MalfunctionJun 14, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, A LEGION CONE HANDLE DID NOT HOLD THE TIBIAL SLEEVE IN PLACE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11991709 ↗
• MalfunctionApr 9, 2021Break; Break

  IT WAS REPORTED THAT DURING AN OFFICE INSPECTION IT WAS FOUND THAT THE END OF THIS LEGION CONE IMPACTOR HANDLE IS BROKEN/CHIPPED. NO CASE INVOLVED THEREFORE NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11642775 ↗
• MalfunctionMar 23, 2021Break; Break

  IT WAS REPORTED THAT AFTER A TKA; THE PIN OF A LGN CONE IMPACTOR HANDLE WAS MISSING. THIS WAS NOTICED AFTER SURGERY; THEREFORE, THE PATIENT WAS NO LONGER INVOLVED AT THAT MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11555687 ↗
• InjuryFeb 28, 2021Break; Break

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, THE PIECE THAT HOLDS THE RASP AND TRIAL OF THE LGN CONE IMPACTOR HANDLE BROKE OFF INSIDE THE PATIENT. ALL THE PIECES WERE ACCOUNTED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE. NO SURGICAL DELAYS AND NO INJURIES TO PATIENT WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391023 ↗
• MalfunctionFeb 14, 2021Break; Break

  IT WAS REPORTED DURING THE TKA PROCEDURE THAT THE TIP WAS CHIPPED OFF. THE INCIDENT OCCURRED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, USING A BACKUP FROM SMITH & NEPHEW. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326130 ↗
• MalfunctionApr 9, 2020Break; Break

  IT WAS REPORTED THAT DURING A REVISION SURGERY THE IMPACTOR BROKE WHILE IMPACTING. IT WAS OUTSIDE THE PATIENT AND ANY PIECE FELL INSIDE THE PATIENT. A SMITH AND NEPHEW BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9945870 ↗
• MalfunctionMar 8, 2018Break; Break

  IT WAS REPORTED THE TIP BROKE DURING SURGERY. NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7323167 ↗
• InjuryOct 16, 2017Fracture; Fracture

  IT WAS REPORTED WHILE SURGEON WAS BROACHING WITH A 28 MM LONG TIBIAL CONE BROACH, THE HANDLE BROKE AND BECAME DETACHED FROM THE BROACH. ONE PIECE OF THE BROKEN HANDLE WAS RETAINED. THE OTHER SMALL FRAGMENT IS BELIEVED TO BE IN THE PATIENT'S INTRAMEDULLARY TIBIAL CANAL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6952219 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162775. One submission often covers many models, so check the product and lot details in each record.

• Z-2624-2017 · May 30, 2017 · Terminated
  LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
• Z-2625-2017 · May 30, 2017 · Terminated
  LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM