NA 71363076Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556111024), received between Sep 3, 2019 and Dec 29, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

4 other recalls cover devices cleared under the same FDA submission (K121393); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 29, 2025Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY, ONE (1) FEMORAL HEAD REDUCER BROKE UNDER NORMAL USE. THE PROCEDURE WAS COMPLETED, AFTER NO DELAY, CHANGING THE SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919177 ↗
• MalfunctionMay 23, 2025Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) FEMORAL HEAD REDUCER BROKE WHILE USING THE INSTRUMENT TO RELOCATE THE HEAD. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078429 ↗
• MalfunctionMay 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR (POSTERIOR APPROACH) SURGERY, THE END OF ONE (1) FEMORAL HEAD REDUCER BROKE OFF DURING THE MOMENT OF REDUCTION. IT DID NOT FALL INTO THE WOUND. THE DOCTOR SIMPLY RETRIEVED THE PIECE WITH HIS FINGERS. IT WAS VERY CLEAR THAT THE BROKEN PIECE AND THE ORIGINAL PIECE FIT BACK TOGETHER, SO WE KNEW THERE WERE NO ADDITIONAL PIECES LEFT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011070 ↗
• MalfunctionJul 30, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, IT WAS NOTICED THAT, THE PLASTIC WORE OUT AND THE FEMORAL HEAD REDUCER SNAPPED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING 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 19861714 ↗
• MalfunctionMay 15, 2024Break; Break

  IT WAS REPORTED THAT, DURING A THR, ONE (1) FEMORAL HEAD REDUCER BROKE WHEN SLIDING THE HEAD INTO THE CUP. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19322630 ↗
• InjurySep 29, 2021Break; Break

  IT WAS REPORTED DURING A THR SURGERY, THAT WHEN THE SURGEON WENT TO REDUCE THE FEMORAL HEAD USING A FEMORAL HEAD REDUCER, TOO MUCH TORQUE WAS APPLIED ON THE INSTRUMENT AND IT SNAPPED IN HALF. NO PIECES FELL INTO THE PATIENT, NO INJURY REPORTED. PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE, NO DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12551073 ↗
• InjuryJul 2, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, AS THE SURGEON WENT TO REDUCE THE HIP, HE LEVERED ON THE AFFECTED DEVICE CAUSING IT TO BREAK. ALL BROKEN PIECES WERE RETRIEVED. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12111780 ↗
• MalfunctionSep 3, 2019Break; Break

  IT WAS REPORTED THAT THE ITEM WAS BROKEN DURING REDUCTION. NO IMPACT/INJURY TO PATIENT, S&N BACKUP AVAILABLE, NO PIECES/PARTS LEFT IN PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8955128 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121393. One submission often covers many models, so check the product and lot details in each record.

• Z-0878-2020 · Dec 16, 2019 · Open, Classified
  LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 714344
• Z-0200-2019 · Sep 18, 2018 · Terminated
  Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to mak
• Z-2163-2018 · May 4, 2018 · Terminated
  smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
• Z-1902-2018 · Apr 9, 2018 · Terminated
  smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic a