JOURNEY 74022124Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00885556170366), received between Jul 25, 2017 and Mar 11, 2026 — classified as 1 death, 26 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 reports).

4 other recalls cover devices cleared under the same FDA submission (K111711, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA WITH AN UNKNOWN DATE, THE JRNY II BCS FEMORAL OXIN LT SZ 4, JOURNEY TIBIA BASE NP LT SZ 4 AND JRNY II BCS XLPE ART ISRT SZ 3-4 LT 12MM WERE EXPLANTED ON A REVISION SURGERY THAT TOOK PLACE ON (B)(6) 2026 DUE TO AN INFECTION. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Medical device site infection

  MAUDE report 24568550 ↗
• InjuryOct 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED LOOSENING OF THE JRNY II BCS FEMORAL OXIN LT SZ 4 DUE TO INFECTION. REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, WHERE ALL PRODUCTS WERE EXCHANGED TO COMPETITOR ONES. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Septic loosening

  MAUDE report 23349488 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, 7 MONTHS AFTER A LEFT TKA NAVIO ASSISTED SURGERY ON (B)(6) 2023, DUE TO PRIMARY OA AND IN WHICH JOURNEY II/ JOURNEY II BCS SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED, THE PATIENT SUFFERED FROM ARTHROFIBROSIS AND WAS SCHEDULED FOR MUA. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Arthrofibrosis

  MAUDE report 21547772 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT TKA SURGERY ON (B)(6) 2023, DUE TO ARTHRITIS AND IN WHICH JOURNEY II/ JOURNEY II BCS SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED, PATIENT SUFFERED ON (B)(6) 2023 FROM A LARGE HEMARTHROSIS THAT REQUIRED ASPIRATION OF JOINT FLUIDS AND TXA MEDICATIONS. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hemarthrosis

  MAUDE report 21547718 ↗
• InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). IT WAS REPORTED THAT AFTER A TKA PERFORMED ON (B)(6) 2017, THE PLAINTIFF EXPERIENCED KNEE ARTHROFIBROSIS WITH A RANGE OF MOTION OF 0-90 DEGREES. A MANIPULATION UNDER ANESTHESIA WAS PERFORMED ON (B)(6) 2017 TO TREAT THESE ADVERSE EVENTS. DURING PROCEDURE THE PLAINTIFF¿S KNEE WAS ABLE TO ACHIEVE 130-DEGREE FLEXION, AND STABILITY WAS SATISFACTORY. PLAINTIFF WAS TRANSPORTED TO RECOVERY ROOM IN STABLE CONDITION.

  Patient problems: Fibrosis; Loss of Range of Motion

  MAUDE report 12720658 ↗
• InjuryApr 29, 2021Adverse 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) 2020, THE PATIENT EXPERIENCED A LIMITED ROM. THE SURGEON SAYS THAT THE DEVICES WERE NOT DEFECTIVE. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2021 TO REPLACE THE JRNY II BCS FEMORAL OXIN LT SZ 4 (CASE- (B)(4)), GNS II RESURF PAT 35MM (CASE- (B)(4)) AND THE JRNY II BCS XLPE ART ISRT SZ 3-4 LT 10MM (CASE- (B)(4)). THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Muscular Rigidity

  MAUDE report 11745424 ↗
• InjurySep 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. A REVISION SURGERY WAS PERFORMED TO TREAT IT: THE JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4 WAS EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 10526111 ↗
• InjuryJun 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 21 MONTHS AGO THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT FOR HER LEFT KNEE AND SHE IS STILL IN INCREDIBLE PAIN, IT OFTEN FEELS VERY WARM AND VERY TIGHT. THERE IS A LARGE INDENTATION ON THE BOTTOM LEFT OF HER KNEE, AND A "KNIFE STABBING" AND "OUT OF PLACE" SENSATION. THE DOCTOR SAID IT WAS THE IMPLANT OPENING UP WHEN BENT. THE PAIN IS OFTEN BELOW THE KNEECAP. THE PATIENT IS USING A PATELLA BRACE, KINESIO TAPE, PHYSICAL THERAPY AND PUTTING ICE ON THE KNEE.

  Patient problems: Pain

  MAUDE report 10199461 ↗
• InjuryApr 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ONE YEAR AFTER PRIMARY SURGERY, REVISION SURGERY HAD TO BE PERFORMED DUE TO DISLOCATION. THE JOURNEY II BCS FEMORAL OXONIUM LEFT SIZE 4 WAS EXCHANGED. DR. STATED THAT THE DEVICES WERE NOT DEFECTIVE.

  Patient problems: Injury

  MAUDE report 9956439 ↗
• InjuryApr 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD DIFFICULT REHABILITATION. PATIENT WAS HOSPITALISED AND UNDERWENT MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 8534354 ↗
• InjuryFeb 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A DEBRIS-CONTAINING SYNOVITIS, LIKELY RELATED TO POLYMERIC WEAR OUTCOME IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 8364494 ↗
• InjuryJan 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO AN INFECTION. THE CAUSE OF THE INFECTION IS UNKNOWN. THE INSERT WAS REPLACED TO A NEW ONE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8244407 ↗
• InjuryDec 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT (B)(6) PRESENTED LEFT KNEE ANKYLOSIS RELATED TO JOURNEY II BCS RETRO IMPLANTS. EVENT WAS TREATED WITH A MANIPULATION UNDER ANESTHESIA.

  Patient problems: Muscular Rigidity

  MAUDE report 8133010 ↗
• InjuryJul 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN 2016, IT WAS REPORTED LATERAL KNEE PAIN AT THE 3 MONTHS FOLLOW-UP VISIT. PATIENT REPORTS THAT PAIN ONSET BEGAN AFTER A STRENUOUS PKT SESSION. FOLLOW UP IN 2018, STATUS OF THE PATIENT REPORTS PERSISTENT, MILD LATERAL KNEE PAIN DURING WALKING AND STAIR CLIMBING.

  Patient problems: Pain

  MAUDE report 7684021 ↗
• InjuryJun 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SURGICAL PROCEDURE IS SCHEDULED FOR EXAMINATION UNDER ANESTHESIC, ARTHROSCOPY AND ARTHROSCOPIC ARTHROLYSIS.

  Patient problems: Pain

  MAUDE report 7561347 ↗
• InjuryMay 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO A MECHANICAL COMPLICATION OF PROSTHETIC JOINT.

  Patient problems: Unspecified Infection

  MAUDE report 7520550 ↗
• InjuryMay 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO ABNORMALITY OF GAIT.

  Patient problems: Limited Mobility Of The Implanted Joint

  MAUDE report 7520302 ↗
• InjuryMay 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO SYNOVITIS.

  Patient problems: Inflammation

  MAUDE report 7520296 ↗
• InjuryJan 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WOULD BE REQUIRED TO CORRECT A PATELLOFEMORAL MALTRACKING.

  Patient problems: Pain

  MAUDE report 7181618 ↗
• InjuryDec 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED POST-OPERATORY PAIN. SUBJECT HAD 10 ML FLUID ASPIRATED AND RECEIVED A DEXAMETHASONE INJECTION

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7143309 ↗
• DeathOct 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT UNDERWENT A TKR ON DATE (B)(6) 2013. ON (B)(6) 2013 THE PATIENT DIED FROM PULMONARY EMBOLISM. THE PULMONARY EMBOLISM WAS DEEMED NOT DEVICE RELATED.

  Patient problems: Death; Pulmonary Embolism

  MAUDE report 6985577 ↗
• InjuryOct 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE REVISION SURGERY, ARTICULAR INSERT WAS REPLACED WHILE OTHER COMPONENTS WERE LEFT IN SITU. INTRAOPERATIVELY IT WAS NOTED THICK SYNOVITIS, BUT THE APPEARANCE OF THE TISSUE WAS NOT CONSISTENT WITH INFECTION. AS PATIENT HAD A (B)(6) NASAL SWAB, VANCOMYCIN WAS STARTED IN THE PRE OP HOLDING AREA. AFTER THE ASPIRATE THE PATIENT WAS ALSO GIVEN 2G OF ANCEF IV.

  Patient problems: Synovitis

  MAUDE report 6960803 ↗
• InjurySep 4, 2017Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT WAS TREATED WITH ORAL ANTIBIOTIC (KEFLEX 300MG 4X1) THERAPY DUE TO LEFT KNEE INFECTION POST TOTAL KNEE ARTHROPLASTY. SEVERITY WAS DEEMED AS MODERATE AND THE OUTCOME OF THE PATIENT IS RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 6841024 ↗
• InjuryAug 29, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT PRESENTED WITH A POST-OPERATIVE WOUND INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6828834 ↗
• InjuryAug 17, 2017Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE PATIENT PRESENTED WITH ABNORMALITY OF GAIT; SYNOVITIS AND TENOSYNOVITIS; LEFT KNEE PAIN DURING THE MONTH/YEARS FOLLOWING, LEFT TKA. THE PATIENT UNDERWENT AN ASPIRATION OF THE LEFT KNEE.

  Patient problems: Pain; Synovitis

  MAUDE report 6802291 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111711, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-0157-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
• Z-0158-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
• 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
• Z-1099-2022 · Apr 19, 2022 · Terminated
  LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5