JOURNEY II 71935194Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556578735), received between Oct 8, 2020 and Dec 12, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (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 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT MEDIAL UNICOMPARTMENTAL KNEE REPLACEMENT HAD BEEN PERFORMED ON AN UNSPECIFIED DATE TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED AN ACUTE INSUFFICIENCY FRACTURE UNDER THE LEFT MEDIAL PLATEAU AFTER A PAINFUL PHYSIOTHERAPY SESSION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 TO TREAT THIS ADVERSE COMPLICATION. DURING THIS PROCEDURE, ALL COMPONENTS WERE REVISED AS THE KNEE WAS CONVERTED TO A TKA. ACCORDING TO THE DATA SET PROVIDED, THIS EVENT OCCURRED 0.5 MONTHS FOLLOWING THE INDEX IMPLANTATION. THE OUTCOME OF THIS PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 15964208 ↗
• InjuryJul 1, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, ON (B)(6) 2020 THE PATIENT HAD 11 DEGREES OF VARUS KNEE ALIGNMENT WHICH WAS CORRECTED TO NEUTRAL DURING UKR OF MEDIAL COMPARTMENT ON (B)(6) 2020. ON (B)(6) 2020, PATIENT PRESENTED PAIN IN THE LATERAL KNEE COMPARTMENT. THEREFORE, ON (B)(6) 2020 THE PATIENT HAD A UKA OF THE LATERAL COMPARTMENT. THE PRE-OPERATIVE AND 3 MONTHS POST-OPERATIVE RADIOGRAPHIC EVALUATION COULD POSSIBLY EXPLAIN THE OVERLOADING OF LATERAL COMPARTMENT AND SUBSEQUENT NEED FOR ADDITIONAL UKR ON THE LATERAL SIDE. ON (B)(6) 2021, THE PATIENT FOLLOWING IMPLANTATION OF AN ADDITIONAL UNI KNEE PROSTHESIS INTO THE SAME KNEE, EXPERIENCED LOOSENING OF THE INITIAL (MEDIAL) UNI KNEE TIBIAL COMPONENT. THEREFORE, ON (B)(6) 2021 THE PATIENT HAD ANOTHER REVISION SURGERY WHERE BOTH UNI KNEES WERE EXPLANTED AND A TKA WAS IMPLANTED. THE EXPLANTS ARE NOT AVAILABLE FOR ANALYSIS, NOR OPERATIVE REPORTS AND X-RAYS YET.

  Patient problems: Failure of Implant; Pain

  MAUDE report 12101254 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A REGULAR POST OPERATIVE ASSESSMENT OF THE PATIENT WAS PERFORMED. THE PATIENT WAS FOUND WITH SEVERE ARTHRO-SYNOVITIS AND A RADIOGRAPH PICTURE SUGGESTED PROBABLE METALLOSIS AND RADIO OPAQUE DEPOSITS AT THE SYNOVIAL LEVEL. A REVISION SURGERY WAS SCHEDULED FOR URGENT SURGICAL CLEANING AND IMPLANT REMOVAL. ON (B)(6) 2020, THE REVISION SURGERY WAS PERFORMED TO REMOVE BAKER CYST AND THE IMPLANTS, WHICH WERE REPLACED WITH A MONO-COMPARTMENTAL SPACER WITH ANTIBIOTIC-LOADED CEMENT. DURING SURGERY, AN INTRACAPSULAR METALOGIC SYNOVITIS (ALSO NEAR THE BAKER CYST) WAS NOTICED. ALSO, THE FOLLOWING IMPLANT FAILURES WERE REMARQUED: DEGENERATION OF THE POLYETHYLENE INSERT IN THE BACK SIDE; CONSUMPTION OF THE CERAMIC AND METAL COATING BELOW THE DISTAL REGION OF THE PROSTHETIC FEMORAL CONDYLE; AND CONSUMPTION OF THE METAL PART IN THE BACK SIDE OF THE TIBIAL COMPONENT.

  Patient problems: Metal Related Pathology; Synovitis

  MAUDE report 10956377 ↗
• MalfunctionOct 8, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY, TWO INSERTS DID NOT FIT INTO THE JII UNI TIBIAL BASEPLATE SZ 2 LM/RL. THE SURGEON THEN DECIDED TO EXPLANT THE PLATE AND INSERT A DEVICE FROM A COMPETITOR BRAND. THE SURGERY WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THIS CAUSED SURGERY TO DELAY. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 10651652 ↗

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