JOURNEY 74027271Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00885556179710), received between Oct 2, 2017 and Mar 7, 2026 — classified as 23 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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. 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2016, THE PATIENT EXPERIENCED INSTABILITY ON HIS RIGHT KNEE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH ONE (1) JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM WAS EXPLANTED AND REPLACED. CURRENT HEALTH STATUS OF PATIENT REMAINS UNCHANGED.

  Patient problems: Joint Laxity

  MAUDE report 24540793 ↗
• InjuryNov 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT AFTER A TKA SURGERY PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A BREAKAGE OF THE POST OF THE JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM. THE ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2025, DURING WHICH THE JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM WAS REMOVED. THE PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23461028 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON (B)(6) 2023, THE PATIENT WAS FOUND TO BE "UNSTABLE" PER SURGEON. ON (B)(6) 2024, THE PATIENT UNDERWENT A REVISION SURGERY, WHERE THE JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM WAS REPLACED WITH A CONSTRAINED VERSION COMPATIBLE WITH THE JOURNEY KNEE SYSTEM. PATIENT LEFT SURGERY IN GOOD HEALTH.

  Patient problems: Joint Laxity

  MAUDE report 20495563 ↗
• InjuryJul 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA PERFORMED ON (B)(6) 2014, THE PATIENT REPORTED PAIN AND SWELLING FOLLOWING A FALL ONTO THE KNEE ON (B)(6) 2024. SUBSEQUENT IMAGING SHOWED THAT THE POST OF THE JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM WAS BROKEN OFF AND FLOATING IN THE KNEE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO ADDRESS THIS ADVERSE EVENT, IN WHICH A NEW INSERT SIZE 10MM WAS REPLACED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOW.

  Patient problems: Failure of Implant; Fall; Pain; Swelling/ Edema

  MAUDE report 19856314 ↗
• InjuryJun 11, 2024Adverse 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) 2014, AROUND A MONTH AGO, THE PATIENT EXPERIENCED INSTABILITY. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2024, DURING WHICH ONE (1) JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM WAS EXCHANGED FOR A 9MM DEEP DISHED INSERT. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.0

  Patient problems: Joint Laxity

  MAUDE report 19515587 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED INFECTION. THIS ADVERSE EVENT WAS TREATED BY A WASHOUT AND REVISION SURGERY ON (B)(6) 2023, IN WHICH A JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 17878056 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA PERFORMED ON (B)(6) 2021, THE PATIENT FELT UNSTABLE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO EXCHANGE THE JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 15899286 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY WAS PERFORMED, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED WITH REVISION SURGERY ON (B)(6) 2022, IN WHICH THE JOURNEY II BCS XLPE ARTICULAR INSERT SIZE 7-8 RIGHT 9MM WAS REPLACED. PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 15136330 ↗
• InjuryJun 14, 2022Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2014, A JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM BROKE. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2022 TO REPLACE THE INSERT. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Loss of Range of Motion

  MAUDE report 14690814 ↗
• InjuryMay 23, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON AN UNKNOWN DATE, THE IMPLANTED JOURNEY II BCS XLPE ARTICULAR INSERT SIZE 7-8 RIGHT 9MM SWAPPED OUT DUE TO LAXITY. NO REPORTED PROBLEM WITH DEVICE ITSELF. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 14480996 ↗
• MalfunctionMay 14, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM FAILED TO INSERT CORRECTLY. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826797 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD SURGERY EARLIER THIS WEEK. HIS INCISION OPENED UP, SO IT WAS WASHED OUT AND THE POLY WAS EXPLANTED.

  Patient problems: Wound Dehiscence

  MAUDE report 10902182 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINT OF PAIN. A REVISION SURGERY WAS PERFORMED AND THE JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM WAS SWAPPED OUT. THERE WAS NO LOOSENING. NO DELAY FOR THIS EVENT. THE PATIENT OUTCOME IS IMPROVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Pain

  MAUDE report 10775595 ↗
• InjuryDec 24, 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 A REVISION SURGERY WAS PERFORMED, PATIENT HAD A CLICKING NOISE WHILE TAKING THE KNEE THROUGH A RANGE OF MOTION TWO DAYS AFTER SURGERY. DR. CLAPS BROUGHT THE PATIENT BACK AND OPENED THE KNEE TO FIND OUT THAT THE BACK OF THE POST WAS DAMAGED AND IT WAS HITTING UP AGAINST A RIDGE OF BONE INSIDE OF THE BOX OF THE FEMUR.

  Patient problems: Injury; No Known Impact Or Consequence To Patient

  MAUDE report 9516210 ↗
• InjurySep 16, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A POLY POST FRACTURE. THE DOCTOR OPTED TO REVISE THE KNEE FROM A 9MM BCS DESIGN TO S&N SIZE 7 RIGHT 13MM JOURNEY II XLPE DEEP DISH POLYETHYLENE ARTICULAR INSERT (74025775,15JM15298) TO MAXIMIZE AXIAL STABILITY AND ELIMINATE THE POTENTIAL RECURRENCE OF THIS POST FRACTURE.

  Patient problems: Injury

  MAUDE report 9070331 ↗
• InjuryAug 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD RIGHT LOWER EXTREMITY EDEMA WITH EXCESSIVE WOUND DRAINAGE, RIGHT FEMORAL DEEP VEIN THROMBOSIS WITH ECCHYMOSIS ABOUT RIGHT THIGH. EVENT WAS RESOLVED WITH MEDICATION.

  Patient problems: Injury; No Code Available

  MAUDE report 8928690 ↗
• InjuryMay 27, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT AFTER KNEE REPLACEMENT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO LIMITED RANGE OF MOTION.

  Patient problems: Injury

  MAUDE report 8643596 ↗
• InjurySep 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INFECTION. FEMORAL COMPONENT AND INSERT WERE REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 7875137 ↗
• InjurySep 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE KNEE POLY WAS REMOVED AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 7840937 ↗
• InjuryMar 28, 2018Material Separation; Material Separation

  REVISION SURGERY DUE TO POLY SEPARATION ON POST.

  Patient problems: No Information

  MAUDE report 7379601 ↗
• InjuryDec 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION OF INSERT, PAIN AND UNCOMFORTABLE FEELING. THE SURGEON CONSIDERED IT IS NOT THE PRODUCT FAILURE.

  Patient problems: Joint Dislocation

  MAUDE report 7106062 ↗
• InjuryNov 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO FLEXION CONTRACTURE. IT WAS ALSO REPORTED THE PATIENT HAD FALLEN DOWN STAIRS AND HAD SWELLING AND PAIN.

  Patient problems: Loss of Range of Motion; Pain; Swelling

  MAUDE report 7069951 ↗
• InjuryNov 29, 2017Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE PATIENT PRESENTED WITH MEDIO-LATERAL INSTABILITY. THE PATIENT UNDERWENT A RIGHT KNEE REVISION SURGERY TO EXCHANGE THE INSERT.

  Patient problems: Injury; Joint Disorder

  MAUDE report 7068102 ↗
• InjuryOct 2, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT PRESENTED WITH RIGHT KNEE GENICULAR NEURALGIA AND RIGHT KNEE PAIN. THE SURGEON PERFORMED PROCEDURES: FLUOROSCOPIC GUIDANCE FOR NEEDLE REPLACEMENT, RIGHT SUPEROMEDIAL GENICULAR BRANCH OF THE SAPHENOUS NERVE BLOCK, RIGHT SUPEROLATERAL GENICULAR BRANCH OF THE FEMORAL NERVE BLOCK, RIGHT INFEROMEDIAL GENICULAR BRANCH OF THE SAPHENOUS NERVE BLOCK, RIGHT MEDIAL GENICULAR BRANCH FROM THE VASTUS INTERMEDIUS NERVE BLOCK.

  Patient problems: Pain

  MAUDE report 6907460 ↗

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-0158-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
• Z-0157-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; 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