JOURNEY 71461014Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY PFJ IMPLANT MEDIUM LEFT · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010544216), received between Jun 19, 2020 and Jan 21, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Degraded” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Degraded1
- Fracture1
- Material Separation1
Patient problems
- Failure of Implant2
- Ambulation or Postural Difficulties1
- Bone Fracture(s)1
- Crepitus1
- Joint Laxity1
- Metal Related Pathology1
- Pain1
- Subluxation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 21, 2025Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A PFJ SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED PATELLA CLUNK. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH THEY REVISED THE IMPLANTS TO A TKA; ALSO THE PATELLA WAS NOTICED TO HAVE MORE WEAR THAN EXPECTED SO IT WAS REVISED TOO. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Ambulation or Postural Difficulties; Crepitus
MAUDE report 21200376 ↗InjuryJun 27, 2023Fracture; Fracture
IT WAS REPORTED THAT, AFTER PARTIAL KNEE REPLACEMENT WAS PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED TROCHLEAR COMPONENT PROTHESIS RUPTURE. THIS COMPLICATION WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2023, IN WHICH THE IMPLANT WAS REPLACED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 17209763 ↗InjuryJun 19, 2020Material Separation; Adverse Event Without Identified Device or Use Problem; Material Separation; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IN REVISION SURGERY THE LEFT KNEE SHOWS A TRANSVERSE FRACTURE, NOT RADIOLOGICALLY VISIBLE. AFTER THAT, IT COULD BE SEEN THAT THE REPLACEMENT (FEMORAL METAL SHIELD) HAS A CHIPPED METAL FRAGMENT. FURTHER INFORMATION IS BEING REQUESTED.
Patient problems: Bone Fracture(s); Failure of Implant; Joint Laxity; Metal Related Pathology; Pain; Subluxation; Synovitis
MAUDE report 10174836 ↗
Other PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER devices
- Scorpio 73-3910Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls4 reports
- Scorpio 73-3508Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls3 reports
- Arthrex® AR-503-TTTCArthrex, Inc. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall15 reports
- Arthrex® AR-503-TTTFArthrex, Inc. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- Scorpio 73-3308Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- Arthrex® AR-504-PSC9Arthrex, Inc. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER11 reports
- Arthrex® AR-504-PSD0Arthrex, Inc. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
- RESTORIS 160405Mako Surgical Corp. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.