JOURNEY PF IMPLANT MED LT

Additional Manufacturer Narrative

RESULTS OF INVESTIGATION: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT AS OF THE DATE OF THIS MEDICAL INVESTIGATION, THE REQUESTED CLINICAL DOCUMENTATION INCLUDING RADIOLOGIC IMAGING, SURGICAL TECHNIQUE, OR OPERATIVE REPORTS, HAS NOT BEEN PROVIDED; THEREFORE, THERE WERE NO CLINICAL FACTORS FOUND WHICH WOULD HAVE DEFINITIVELY CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT IMPACT BEYOND THE REPORTED EVENTS INCLUDING THE REVISION/REPLACEMENT OF COMPONENTS CANNOT BE DETERMINED AND THE PATIENT CURRENT HEALTH WAS NOT PROVIDED. THEREFORE, NO FURTHER CLINICAL/MEDICAL ASSESSMENT CAN BE RENDERED AT THIS TIME. 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 THE IMPLANT CAN BREAK OR BECOME DAMAGED AS A RESULT OF STRENUOUS ACTIVITY OR TRAUMA. THE PATIENT SHOULD BE WARNED THAT THE DEVICE DOES NOT REPLACE NORMAL HEALTHY BONE. THIS HAS BEEN IDENTIFIED IN WARNINGS AND PRECAUTIONS. 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. VERIFYING THE DEVICE CONFIGURATION ACCORDING TO THE DRAWING PRINT IS WITHIN THE STEPS OF THE FINAL INSPECTION. ADDITIONALLY, ACCORDING TO THE MATERIAL SPECIFICATION, THE QUALITY AND MANUFACTURE OF WROUGHT BAR SHALL BE CONTROLLED. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED EVENT INCLUDE ABNORMAL LOADING OF LIMB, EXCESSIVE FORCES AND/OR TRAUMATIC INJURY. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD THE DEVICE OR 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.

Description of Event or Problem

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.

Additional Manufacturer Narrative

H10: INTERNAL COMPLAINT REFERENCE (B)(4). NCA: (B)(6). REPORT NUMBER: (B)(4).