JOURNEY II XR 74022206Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556615362), received between Sep 26, 2018 and Oct 22, 2020 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K152726, 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT SUFFER FROM LEFT KNEE CELLULITIS, SURGERY WAS ON (B)(6) 2018. IT WAS TREATED WITH SULFAMETHOXAZOLE-TRIMETHOPRIM. THE OUTCOME IS RESOLVED. NO MORE INFORMATION PROVIDED AT THIS TIME.

  Patient problems: Cellulitis

  MAUDE report 10722186 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PRIMARY TKA IN WHICH JOURNEY XR COMPONENTS HAD BEEN IMPLANTED, THE PATIENT COMPLAINED ABOUT INSTABILITY. A REVISION SURGERY WAS PERFORMED TO EXCHANGE THE TIBIAL COMPONENT AND PLACE A NEW INSERT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 10514336 ↗
• InjuryAug 31, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE JRNY II XR BASEPLATE SZ 6 LT WAS REMOVED IN A REVISION SURGERY ON (B)(6) 2020 DUE TO PATIENT INSTABILITY. A JOURNEY PRIMARY TIBIA WITH RETAINING INSERT WAS IMPLANTED IN REVISION SURGERY.

  Patient problems: Injury; Joint Disorder

  MAUDE report 10474877 ↗
• 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 9378605 ↗
• InjuryNov 12, 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 9313375 ↗
• 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 9313371 ↗
• InjurySep 26, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH RECENT XR IMPLANT (SURGERY (B)(6) 2018) RETURNED WITH COMPLAINTS OF KNEE PAIN. UPON X-RAY REVIEW WITH DOCTOR, IT APPEARED THAT THE PATIENT'S PATELLA HAS ROTATED VERTICALLY. DOCTOR MENTIONED THAT HE BELIEVED THE INCIDENT AND LACK OF PATELLA TRACKING TO BE ASSOCIATED WITH THE XR TIBIAL BASEPLATE, ALTHOUGH HE WAS NOT SURE. THE PATIENT HAS BEEN SCHEDULED TO HAVE THEIR PATELLA RESURFACED, ORIGINAL PRIMARY XR TKA COMPONENTS ARE NOT PLANNED TO BE REPLACED AS THERE WAS NO MENTION OF ISSUES WITH THE COMPONENTS THEMSELVES BEING FAULTY.

  Patient problems: Pain

  MAUDE report 7911059 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152726, 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