JOURNEY PF IMPLANT MED LT

Description of Event or Problem

IT WAS REPORTED THAT, AFTER A RIGHT PATELLOFEMORAL SURGERY WAS PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED INCREASE IN PAIN. X-RAYS WERE PERFORMED ON (B)(6) 2023 AND THEY WERE UNREMARKABLE. HOWEVER, ON (B)(6) 2023 X-RAYS REVEALED THERE WAS A VISIBLE FRACTURE OF THE TROCHLEA AND A POSTERIOR RUPTURE ON THE SURFACE OF THE JOURNEY PF IMPLANT MED RT. THIS EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2024, DURING WHICH THE FRACTURED FEMORAL COMPONENT WAS REMOVED. PATIENT'S HEALTH STATUS IS GOOD. REPLACEMENT OPERATION WENT WELL.

Additional Manufacturer Narrative

H10- ADDITIONAL INFORMATION. D10- CONCOMITANT MEDICAL PRODUCTS. G4- PMA/510(K)NUMBER H11- CORRECTED DATA. B5- DESCRIBE EVENT OR PROBLEM. D1- BRAND NAME. D4- CATALOG NUMBER, LOT NUMBER, EXPIRATION DATE, UNIQUE IDENTIFIER (UDI) #. H4- DEVICE MANUFACTURE DATE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H6 (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS). RESULTS OF INVESTIGATION: THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE PHOTOGRAPHS WERE REVIEWED, AND REVEALED THAT THE DEVICE IS FRACTURED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, BASED ON THE LIMITED INFORMATION PROVIDED, THE DEFINITIVE CLINICAL ROOT CAUSE OF THE REPORTED PAIN, FRACTURE OF THE TROCHLEA AND THE POSTERIOR SURFACE RUPTURE CANNOT BE DETERMINED. THE PATIENT'S BODY MASS INDEX OF 42, AND METABOLIC SYNDROME AS LIKELY CONTRIBUTORY FACTORS TO THE REPORTED PAIN AND REVISION. IT IS UNKNOWN IF THE INSTRUCTIONS FOR USE FOR KNEE SYSTEMS, WAS ADHERED TO. ACCORDING TO THE REPORT, THE REVISION SURGERY WENT WELL, AND THE PATIENT IS IN GOOD HEALTH. THE PATIENT IMPACT IS DETERMINED TO BE THE REVISION. A REVIEW OF THE PRODUCTION ORDER DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF COMPLAINT HISTORY FOR THE PART NUMBER OVER THE PAST 12 MONTHS AND FOR THE BATCH NUMBER BASED ON HISTORICAL DATA OF THE DEVICE DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICE. A REVIEW OF THE INSTRUCTIONS FOR USE DOCUMENTS FOR KNEE SYSTEMS REVEALED THAT BREAK OF IMPLANT HAS BEEN IDENTIFIED IN WARNINGS AND PRECAUTIONS SECTION AS A RESULT OF STRENUOUS ACTIVITY OR TRAUMA. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS PRODUCT AND EVENT. ACCORDING WITH INSPECTION PROCEDURE, THE FINAL INSPECTION INCLUDES THE VERIFICATION OF PART CONFIGURATION PER PRINT. ALSO, PER MATERIAL SPECIFICATION, THE QUALITY AND MANUFACTURE OF ZIRCONIUM-2.5% NIOBIUM ALLOY WROUGHT BAR SHALL BE CONTROLLED. AT THIS TIME, WE HAVE NO EVIDENCE TO CONCLUDE THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED. CORRECTED DATA: D9 (ITEM WAS DISCARDED AT THE FACILITY).

Description of Event or Problem

IT WAS REPORTED THAT, AFTER A LEFT MEDIAL UKA SURGERY WAS PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED INCREASE IN PAIN. X-RAYS WERE PERFORMED ON (B)(6) 2023 AND THEY WERE UNREMARKABLE. HOWEVER, ON (B)(6) 2023 X-RAYS REVEALED THERE WAS A VISIBLE FRACTURE OF THE TROCHLEA AND A POSTERIOR RUPTURE ON THE SURFACE OF THE JOURNEY PF IMPLANT MED LT. THIS EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2024, DURING WHICH THE FRACTURED FEMORAL COMPONENT WAS REMOVED. PATIENT'S HEALTH STATUS IS GOOD. REPLACEMENT OPERATION WENT WELL.

Description of Event or Problem

IT WAS REPORTED THAT, AFTER TKA SURGERY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UNSPECIFIED COMPLICATIONS THAT REQUIRED A REVISION SURGERY ON (B)(6) 2024. DURING THIS PROCEDURE, THE JOURNEY PFJ FEMORAL COMPONENT WAS FOUND TO BE FRACTURED OFF. PATIENT'S OUTCOME IS UNKNOWN.

Additional Manufacturer Narrative

H10: INTERNAL COMPLAINT REFERENCE CASE (B)(4).