UNKNOWN JOURNEY PFJ KNEE IMPLANT

Additional Manufacturer Narrative

INTERNAL REFERENCE NUMBER: (B)(4). DOI: HTTPS://DOI.ORG/10.1016/J.ARTH.2025.06.035. THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION IDENTIFIED THROUGH A REVIEW OF CLINICAL EVIDENCE FROM LITERATURE SOURCES THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT. THE REPORTED ISSUE(S) RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

Description of Event or Problem

ON THE LITERATURE REVIEW "CAN ROBOTIC-ASSISTED ARTHROPLASTY CHANGE THE HIGH EARLY REVISION RATE AFTER PATELLO-FEMORAL ARTHROPLASTY? AN ANALYSIS FROM THE AUSTRALIAN ORTHOPAEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY", IT WAS REPORTED THAT, AFTER A HUNDRED AND NINETY-NINE (199) KNEES UNDERWENT CONVENTIONAL PATELLOFEMORAL ARTHROPLASTY IN WHICH A GENESIS II/JOURNEY SYSTEM WAS PLACED, NINETEEN (19) KNEES WERE REVISED. DUE TO THE STRATIFICATION OF THE DATA PRESENTED IN THIS STUDY, THE NUMBER OF REVISIONS PERFORMED BY REASON FOR REVISION CANNOT BE DETERMINED.