JOURNEY II 71935200Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556578797), received between Sep 30, 2019 and Dec 1, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

1 other recall cover devices cleared under the same FDA submission (K152315, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2022Migration; Migration

  IT WAS REPORTED THAT, AFTER A UKR SURGERY WAS PERFORMED ON (B)(6) 2022, PATIENT EXPERIENCED MEDIAL KNEE PAIN ASSOCIATED WITH TIBIAL COMPONENT SUBSIDENCE. THIS ADVERSE EVENT WAS IDENTIFY BY A CLINICAL STUDY ON (B)(6) 2022. A REVISION SURGERY HAS BEEN PLANNED. PATIENT'S CURRENT HEALTH STATUS IS ONGOING.

  Patient problems: Pain

  MAUDE report 15895872 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A PRIMARY TKA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT'S RIGHT KNEE ON (B)(6) 2020, THE PATIENT EXPERIENCED LOOSENING OF THE TIBIAL COMPONENT, AS WELL AS AN EDEMA, WEAKNESS, LOSS OF RANGE OF MOTION, PAIN AND SWELLING. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. THE OUTCOME IS RESOLVED.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Joint Laxity; Loss of Range of Motion; Muscle Weakness/Atrophy; Pain; Swelling/ Edema

  MAUDE report 10897183 ↗
• InjuryOct 7, 2019Fracture; Fracture

  IT WAS REPORTED THAT A PAST PERIPROSTHETIC TIBIA FRACTURE OCCURRED WITH CALLUS FORMATION AROUND THE TIBIA AND WITHOUT LOOSENING. A REVISION SURGERY WILL NOT BE PERFORMED BUT TWO CRUTCHES WERE PROVIDED TO THE PATIENT TO UNLOAD THE OPERATED LIMB. UP TO THE (B)(6) 2019 THE PATIENT DID NOT REPORT ANY COMPLAINT OR PROBLEM, BUT A PERIPROSTETIC FRACTURE WAS IDENTIFIED ON THE X-RAY TAKEN SAME DATE (AUG 28, 2019), DURING THE THREE MONTHS VISIT. IT WAS OBSERVED THAT THE MENTIONED FRACTURE WAS NEARLY CURED. PATIENT DID NOT COMPLAINT OF ANY PAIN OR WALKING PROBLEMS THAT TIME. IT WAS INFORMED BY THE PATIENT THAT EARLY DURING POSTOPERATIVE PERIOD, SHE EXPERIENCED SYMPTOMS OF PAIN AND A EDEMA AROUND THE KNEE, BUT NO HISTORY OF INJURY. SYMPTOMS WERE RESOLVED WITH HEPARIN AND ANTI-EDEMA DRUGS A FEW DAYS AFTER PATIENT WENT TO THE ER ON 8 JULY 2019.

  Patient problems: Injury

  MAUDE report 9164268 ↗
• InjurySep 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO TIBIAL PLATEAU NECROSIS.

  Patient problems: Necrosis

  MAUDE report 9137567 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152315, 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