JOURNEY PF IMPLANT MED LT

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE: (B)(4). ADDITIONAL INFORMATION: D5, D7A, D8, E1 (NAME PREFIX/TITLE), H8 CORRECTED DATA: B1, B5, H6 (MEDICAL DEVICE PROBLEM CODE, HEALTH EFFECT - CLINICAL CODE).

Description of Event or 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.

Additional Manufacturer Narrative

H10: (B)(4) WAS FOUND TO BE A DUPLICATE OF (B)(4); SINCE BOTH CASES COVER THE SAME REVISION SURGERY PERFORMED DUE TO THE PATIENT EXPERIENCING A PATELLAR CLUNK. THEREFORE, (B)(4) (WHERE THE JOURNEY PF IMPLANT MED LT WAS REPORTED) WILL BE CLOSED AND (B)(4) (WHERE THE GII/LEGION RESURF PAT W/JRNY PEG 29MM WAS REPORTED) WILL REMAIN OPEN. THE INVESTIGATION AND FINDINGS FOR BOTH IMPLANTS WILL BE DOCUMENTED UNDER (B)(4). FROM NOW ON, THIS REPORT WILL BE COVERED UNDER REPORT NUMBER: (B)(4).

Additional Manufacturer Narrative

THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION RELATED TO A PRODUCT PROBLEM WITH A SMITH+NEPHEW DEVICE. THE REPORTED ISSUE(S) RELATE TO KNOWN INHERENT DEVICE AND/OR 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 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 SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INVESTIGATIVE FINDINGS OR INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

Description of Event or Problem

IT WAS REPORTED THAT, AFTER A TKA 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 TOTAL KNEE, AND REVISED ONE (1) JOURNEY PF IMPLANT MED LT BY EXPLANTING IT AND NOTICED IT TO HAVE MORE WEAR THAN EXPECTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.