JOURNEY II XR 74022294Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00885556615423), received between Jul 26, 2018 and May 21, 2022 — classified as 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2019, THE PATIENT TORE THEIR ANTERIOR CRUCIATE LIGAMENT (ACL). THE ADVERSE EVENT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022, IN WHICH THE JRNY II XR BASEPLATE SZ 4 RT WAS EXPLANTED ALONG WITH THE INSERT. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Damage to Ligament(s)

  MAUDE report 14466689 ↗
• InjuryMay 28, 2020Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT PRESENTED RIGHT KNEE STIFFNESS POST RIGHT TOTAL KNEE ARTHROPLASTY. EVEN WAS RESOLVED WITH MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury; Limited Mobility Of The Implanted Joint

  MAUDE report 10099191 ↗
• InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  [STUDY: JOURNEY II XR; SUBJECT ID: (B)(6); AE#: 2] IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED IN WHICH A JOURNEY II XR SYSTEM WAS IMPLANTED, THE CLINICAL SUBJECT SUFFERED FROM A MSSA INFECTION. A REVISION SURGERY WAS PERFORMED TO TREAT THE ADVERSE EVENT. THE EVENT IS RESOLVED.

  Patient problems: Bacterial Infection

  MAUDE report 10096955 ↗
• InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, AFTER A PRIMARY TKA SURGERY HAD BEEN PERFORMED WITH A JOURNEY II SYSTEM, THE CLINICAL SUBJECT EXPERIENCED OCCASIONAL SWELLING AND PAIN. THE IMPLANTED TKR SYSTEM FAILED: IT IS BELIEVED THAT TIBIAL LOOSENING WAS IMPLICATED. A REVISION SURGERY WAS PERFORMED TO EXPLANT THE JOURNEY II BASEPLATE COMPONENT. AN S&N LEGION SYSTEM WAS IMPLANTED INSTEAD. THE EVENT IS CONSIDERED AS RESOLVED.

  Patient problems: Arthralgia; Joint Swelling

  MAUDE report 10027434 ↗
• InjuryApr 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLINICAL SUBJECT PRESENTED POSTOPERATIVE RIGHT KNEE STIFFNESS. THE EVENT WAS TREATED VIA MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 10015678 ↗
• InjuryNov 12, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO STIFFNESS. THE PATELLA WAS NOT REPLACED.

  Patient problems: Injury

  MAUDE report 9313381 ↗
• InjuryJun 30, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT HAD AN ARTHROSCOPY DUE TO PERSISTENT CLUNKING AND POPPING.

  Patient problems: Injury

  MAUDE report 8746878 ↗
• InjuryJun 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED INTRA-OP MEDIAL TIBIAL PLATEAU FRACTURE WITH ORIF AND SUBSEQUENT HARDWARE REMOVAL DUE TO PERSISTENT PAIN. ADVERSE EVENT WAS RESOLVED.

  Patient problems: Pain

  MAUDE report 8746860 ↗
• InjuryJun 29, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT RIGHT KNEE STIFFNESS WAS RESOLVED WITH MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 8746773 ↗
• InjuryJun 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED PES ANSERINUS WHICH WAS TREATED USING REPEAT DEPO MEDROL STEROID INJECTIONS.

  Patient problems: Injury

  MAUDE report 8683725 ↗
• InjuryJun 10, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT PRESENTED A LIMITED RANGE OF MOTION DURING 6 WEEKS POST OP VISIT, AND IT PROCEEDED WITH MANIPULATION UNDER ANESTHESIA. POST OP VISIT AFTER MUA, THE PATIENT WAS GIVEN DYNASPLINT TO IMPROVE EXTENSION. 6 WEEKS POST MUA PATIENT'S RANGE OF MOTION WAS SIGNIFICANTLY IMPROVED.

  Patient problems: Injury

  MAUDE report 8683713 ↗
• InjuryJan 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD STIFFNESS AND PAIN A MONTH AFTER THE PRIMARY SURGERY. A MANIPULATION UNDER ANESTHESIA WAS PERFORMED AND AN ASPIRATION AND A MARCAINE INJECTION WERE GIVEN TO PATIENT.

  Patient problems: Injury; Pain

  MAUDE report 8279292 ↗
• InjuryJan 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT REQUIRED A REVISION SURGERY BECAUSE OF PAIN AND DISCOMFORT.

  Patient problems: Pain

  MAUDE report 8269116 ↗
• InjuryJul 26, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MEDICAL INTERVENTION WAS PERFORMED DUE TO STIFFNESS.

  Patient problems: No Code Available

  MAUDE report 7721438 ↗

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