JOURNEY 74021167Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00885556422762), received between Jul 23, 2018 and Jun 22, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 reports).

1 other recall cover devices cleared under the same FDA submission (K121443, 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2016, THE PATIENT EXPERIENCED A LEFT KNEE PAIN DUE TO LEFT KNEE EFFUSION. THIS ADVERSE EVENT WAS DIAGNOSIS BY A CLINICAL STUDY AND TREATED WITH INJECTION/ASPIRATION. PATIENT'S CURRENT HEALTH STATUS IS RECOVERED.

  Patient problems: Joint effusion; Pain

  MAUDE report 25586540 ↗
• InjuryDec 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT TKA SURGERY PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED A NON-OCCLUSIVE LOW ECHOGENICITY THROMBOSIS WITHIN THE POPLITEAL VEIN ON (B)(6) 2018. TO TREAT THE CONDITION THE PATIENT WAS ADMINISTERED MEDICATION. THE CONDITION WAS REPORTED AS RESOLVED WITH SEQUELAE ON (B)(6) 2019. FURTHER DETAILS REGARDING THE PATIENT'S CURRENT HEALTH CONDITION AND THE SPECIFIC DETAILS OF THE SEQUELAE ARE CURRENTLY UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18423034 ↗
• InjuryDec 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED LEFT KNEE SORENESS, PAIN AND SWELLING. IT WAS TREATED CONSERVATIVELY. THE OUTCOME OF THE PATIENT IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 10932147 ↗
• InjuryApr 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT PRESENTED LEFT KNEE ARTHROFIBROSIS. ADVERSE EVENT WAS TREATED WITH MANIPULATION UNDER ANESTHESIA. EVENT WAS RESOLVED.

  Patient problems: Injury

  MAUDE report 10013670 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER SURGERY, THE PATIENT PRESENTED ARTHROFIBROSIS OF LEFT KNEE. MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO RESOLVE THE ISSUE.

  Patient problems: Injury

  MAUDE report 9377893 ↗
• InjuryNov 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS OF LEFT KNEE.

  Patient problems: Injury

  MAUDE report 9313374 ↗
• InjuryOct 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER SURGERY PATIENT HAD PERONEAL VEIN THROMBOSIS AND CELLULITIS IN LEFT KNEE. MEDICATION THERAPY WAS USED TO RESOLVE THE EVENT.

  Patient problems: Pain

  MAUDE report 9255824 ↗
• InjurySep 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH BETADINE AND ANTIBIOTIC DUE TO A SUTURE REACTION. THE EVENT WAS RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 8967374 ↗
• InjuryAug 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO PULMONARY EMBOLISM. AND TREATED WITH AN UNKNOWN REMEDIAL THERAPY.

  Patient problems: Injury

  MAUDE report 8867778 ↗
• InjuryJun 23, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD PERSISTENT HEARTBURN/CHEST PAIN FOR WEEKS PRIOR TO HOSPITALIZATION, HE BELIEVED THIS WAS DUE TO GERD. HE WAS THEN ADMITTED TO THE HOSPITAL AND REQUIRED STENT AND BYPASS AFTER CARDIAC TESTING.

  Patient problems: Injury; Myocardial Infarction

  MAUDE report 8725628 ↗
• InjuryJun 23, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER 8 WEEKS POST-OP, THE PATIENT STILL HAD LIMITED RANGE OF MOTION AFTER AGGRESSIVE PHYSICAL THERAPY, FOR WHICH MANIPULATION UNDER ANESTHESIA WAS REQUIRED DUE TO THE STIFFNESS.

  Patient problems: Injury; Neck Stiffness

  MAUDE report 8725621 ↗
• InjuryJul 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS.

  Patient problems: Injury

  MAUDE report 7712360 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121443, 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