JOURNEY II 71935205Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556578841), received between Dec 7, 2020 and Jul 1, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (2 reports).

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.

• InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: Arthralgia; Failure of Implant; Inadequate Osseointegration; Pain

  MAUDE report 12103782 ↗
• MalfunctionFeb 28, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A SURGERY, THE SURGEON ENCOUNTERED DIFFICULTIES IN PLACING A UNI-COMPARTMENTAL KNEE PROSTHESIS INSERT FROM THE JOURNEY UNI 2 RANGE. THE INSERT WAS EVENTUALLY DAMAGED DUE TO ITS DIFFICULT INSERTION, SO THE SURGEON CHANGED IT TO ANOTHER IDENTICAL INSERT (SAME BATCH AND SIZE). THIS SECOND INSERT GAVE THE SAME DIFFICULTIES AND THE SAME RESULT: IT WAS IMPOSSIBLE TO INSERT IT INTO THE TIBIAL BASE DESPITE THE SURGEON ONCE AGAIN IMPLEMENTING ALL THE PRECAUTIONS (PULSED WASHING, DRYING AND CHECKING THAT THERE WAS NO INTERPOSITION BY SOFT PARTS, CEMENT OR BLOOD). AS A RESULT, THE SURGEON TOOK A NEW INSERT, IDENTICAL BUT FROM A DIFFERENT BATCH, WHICH SNAPPED INTO THE TIBIAL BASE QUITE NORMALLY. THERE WERE NO IMMEDIATE CONSEQUENCES FOR THE PATIENT, APART FROM AN EXTENSION OF A FEW MINUTES OF THE OPERATING TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391040 ↗
• MalfunctionFeb 28, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A SURGERY, THE SURGEON ENCOUNTERED DIFFICULTIES IN PLACING A UNI-COMPARTMENTAL KNEE PROSTHESIS INSERT FROM THE JOURNEY UNI 2 RANGE. THE INSERT WAS EVENTUALLY DAMAGED DUE TO ITS DIFFICULT INSERTION, SO THE SURGEON CHANGED IT TO ANOTHER IDENTICAL INSERT (SAME BATCH AND SIZE). THIS SECOND INSERT GAVE THE SAME DIFFICULTIES AND THE SAME RESULT: IT WAS IMPOSSIBLE TO INSERT IT INTO THE TIBIAL BASE DESPITE THE SURGEON ONCE AGAIN IMPLEMENTING ALL THE PRECAUTIONS (PULSED WASHING, DRYING AND CHECKING THAT THERE WAS NO INTERPOSITION BY SOFT PARTS, CEMENT OR BLOOD). AS A RESULT, THE SURGEON TOOK A NEW INSERT, IDENTICAL BUT FROM A DIFFERENT BATCH, WHICH SNAPPED INTO THE TIBIAL BASE QUITE NORMALLY. THERE WERE NO IMMEDIATE CONSEQUENCES FOR THE PATIENT, APART FROM AN EXTENSION OF A FEW MINUTES OF THE OPERATING TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391039 ↗
• 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 10956376 ↗

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