JOURNEY 74022218Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010554413), received between Oct 3, 2017 and Oct 1, 2020 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

4 other recalls cover devices cleared under the same FDA submission (K042515, K091014, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING PROCEDURE UPON OPENING THE STERILE INNER PACKAGING, IT WAS NOTICED THE IMPLANT HAD WHITE FLAKES ON IT. A DUPLICATE IMPLANT WAS OPENED AND USED. NO DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10617219 ↗
• InjuryNov 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH SYNCOPE AFTER SURGERY. HOSPITALIZATION WAS REQUIRED.

  Patient problems: Injury

  MAUDE report 9356564 ↗
• InjuryNov 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH ACUTE KIDNEY INJURY AFTER SURGERY. HOSPITALIZATION WAS REQUIRED.

  Patient problems: Injury

  MAUDE report 9356530 ↗
• InjuryAug 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD RIGHT LOWER EXTREMITY EDEMA WITH EXCESSIVE WOUND DRAINAGE, RIGHT FEMORAL DEEP VEIN THROMBOSIS WITH ECCHYMOSIS ABOUT RIGHT THIGH. EVENT WAS RESOLVED WITH MEDICATION.

  Patient problems: Injury; No Code Available

  MAUDE report 8928691 ↗
• InjuryMar 20, 2019Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY. RIGHT TKR POLY WAS EXCHANGED.

  Patient problems: Injury

  MAUDE report 8436615 ↗
• InjuryOct 3, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT PRESENTED WITH RIGHT KNEE GENICULAR NEURALGIA AND RIGHT KNEE PAIN. THE SURGEON PERFORMED PROCEDURES: FLUOROSCOPIC GUIDANCE FOR NEEDLE REPLACEMENT, RIGHT SUPEROMEDIAL GENICULAR BRANCH OF THE SAPHENOUS NERVE BLOCK, RIGHT SUPEROLATERAL GENICULAR BRANCH OF THE FEMORAL NERVE BLOCK, RIGHT INFEROMEDIAL GENICULAR BRANCH OF THE SAPHENOUS NERVE BLOCK, RIGHT MEDIAL GENICULAR BRANCH FROM THE VASTUS INTERMEDIUS NERVE BLOCK.

  Patient problems: Pain

  MAUDE report 6910626 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042515, K091014, 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-0003-2019 · Jun 13, 2018 · Open, Classified
  JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 7402312
• Z-0001-2019 · Jun 13, 2018 · Open, Classified
  Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 7
• Z-0002-2019 · Jun 13, 2018 · Open, Classified
  JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 7402112