JOURNEY 74021113Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010554055), received between Jun 2, 2022 and Jun 2, 2022 — classified as 3 injuries.

3 other recalls cover devices cleared under the same FDA submission (K042515); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S RIGHT KNEE ON (B)(6) 2007, THE PATIENT EXPERIENCED A PERIPROSTHETIC MULTI-FRAGMENTARY RORABECK TYPE II FRACTURE OF THE DISTAL FEMORAL SPIRAL ON THE RIGHT LIMB DUE TO A FALL. TO TREAT THIS ADVERSE EVENT, THE PATIENT UNDERWENT AN OPEN REDUCTION AND OSTEO-SYNTHETIC SURGERY ON (B)(6) 2021.

  Patient problems: Fall; Limb Fracture

  MAUDE report 14579686 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA PROSTHESIS CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S RIGHT KNEE ON (B)(6) 2022, THE PATIENT EXPERIENCED A MECHANICAL COMPLICATION OF THE JOINT, OSTEOPHYTE FORMATION, PAIN AT THE JOINT, RESTRICTED MOBILITY AND PLICA SYNDROME. AN ADDITIONAL SURGERY WAS PERFORMED ON (B)(6) 2022 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, AN OPEN ARTHROTOMY OF THE PATELLA WITH MODELLING AND DENERVATION WAS PERFORMED, ALONG WITH THE RESECTION OF THE OSTEOPHYTES, PLICAR RESECTION AND RESECTION OF NODE RINGS WITH PLASTIC RECONSTRUCTION IN CONGENITAL ANOMALIES. A 32MM RESURFACED PATELLA WAS IMPLANTED. THE PATIENT REPORTS TO BE EXPERIENCING SOME SWELLING AND PAIN AFTER THIS INTERVENTION.

  Patient problems: Arthralgia; Extraskeletal ossification; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 14579299 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S RIGHT KNEE ON (B)(6) 2007, THE PATIENT EXPERIENCED ARTHROFIBROSIS AND DECREASED RANGE OF MOTION IN THE KNEE. AN ARTHROLYSIS WAS PERFORMED ON (B)(6) 2007 TO TREAT THIS ADVERSE EVENT. FURTHER INFORMATION FROM THE FOLLOW UPS AFTER THIS PROCEDURE IS NOT KNOWN.

  Patient problems: Fibrosis; Loss of Range of Motion

  MAUDE report 14578621 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042515. One submission often covers many models, so check the product and lot details in each record.

• Z-0001-2019 · Jun 13, 2018 · Open, Classified
  Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 7
• Z-0003-2019 · Jun 13, 2018 · Open, Classified
  JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 7402312
• Z-0002-2019 · Jun 13, 2018 · Open, Classified
  JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 7402112