JOURNEY 74012905Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010556943), received between Jun 1, 2021 and Oct 5, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT A QUICK CON DRILL PIN 1/8 X 5 WAS BROKEN. IT IS UNCLEAR WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544571 ↗
• InjuryDec 27, 2021Break; Break

  IT WAS REPORTED THAT, DURING A KNEE REPLACEMENT, WHILE USING THE QUICK CONNECT DRILL PIN 1/8 X 5 TO MAKE A PLACE FOR TROCAR PINS, THE DRILL BROKE AND BROKEN PIECES WENT INSIDE THE BONE. TO REMOVE THE BROKEN PIECES, THE SURGEON DIGGED OUT THE BONE AROUND THE BROKEN PIECE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. A LESS THAN OR EQUAL TO 30 MINS DELAY WAS REPORTED AS A CONSEQUENCE OF THIS PROBLEM. NO FURTHER ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13089647 ↗
• InjuryJun 23, 2021Break; Break

  IT WAS REPORTED, THAT DURING A JOURNEY PFJ PROCEDURE, A QUICK CONNECT 1/8¿ DRILL BIT BROKE IN THE BLOCK AND FEMUR, INSIDE THE PATIENT. SURGERY WAS COMPLETED, WITHOUT SIGNIFICANT DELAY, BY USING THE SAME DEVICE. THE PATIENT WAS NOT HARMED BEYOND WHAT HAS BEEN DESCRIBED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054133 ↗
• InjuryJun 1, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, AFTER A TKA PERFORMED ON (B)(6) 2021 A FRAGMENT FROM A QUICK CONNECT DRILL PIN 1/8 X 5 WAS DISCOVERED IN THE VENTRO-MEDIAL TIBIAL REGION, AFTER A POSTOPERATIVE RADIOGRAPHY WAS PERFORMED. A REVISION SURGERY TOOK PLACE ON (B)(6) 2021 TO REMOVE THE COMPLETE FRAGMENT. THE PATIENT WAS NOT INJURED BEYOND THE DESCRIBED EVENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11916873 ↗

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