PROFEMUR® MODULAR FEMORAL NECK

Additional Manufacturer Narrative

THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

Description of Event or Problem

ALLEGEDLY, AN ABNORMAL NOISE WAS OBSERVED DURING STARTUP, AND IT WAS SUSPECTED THAT THE NECK MAY HAVE FRACTURED. THE PHYSICIAN COMMENTED "IT OCCURRED BECAUSE THE PATIENT WAS A YOUNG AND HIGHLY ACTIVE FISHERMAN. HE HAS REQUESTED INFORMATION SHARING ON DOMESTIC CASES OF NECK FRACTURES AND THEIR BACKGROUND IN JAPAN, AND ON HOW TO APPROPRIATE RESPOND WHEN SIMILAR INCIDENTS OCCUR IN THE FUTURE. ACCORDING TO THE SALES REP, THE PATIENT WAS RELATIVELY YOUNG (54 YEARS AT THE TIME OF PRIMARY SURGERY AND 56 YEARS AT THE TIME OF FRACTURE), A PROFESSIONAL FISHERMAN WITH HIGH PHYSICAL ACTIVITY, AND USED A LONG-NECK - ALL OF WHICH WERE CONSIDERED SIGNIFICANT RISK FACTORS FOR THE FRACTURE., HOWEVER HIS PHYSIQUE WAS AVERAGE:167CM IN HEIGHT, 56.8KG IN WEIGHT, WITH A BMI PF 20.37. ALL PARTIES INVOLVED WERE SURPRISED THAT THE FRACTURE OCCURRED WITHIN JUST TWO YEARS. (B)(4).

Additional Manufacturer Narrative

THE ALLEGED COMPLAINT COULD NOT BE CONFIRMED. REVIEW OF THE COMPLAINT, PHA01254 LOT 0374216371927298, DOES NOT REVEAL ANY EVIDENCE OF FAILURE INVOLVING THIS IMPLANT. THIS IMPLANT WAS NOT RETURNED FOR INVESTIGATION, NOR WERE ANY PICTURES, RADIOGRAPHIC IMAGES, OR OTHER MEDICAL DOCUMENTATION PROVIDED TO ASSIST WITH THE COMPLAINT INVESTIGATION. THIS IMPLANT WAS IMPLANTED INTO THE 56 YO MALE PATIENT IN 2023 BEFORE REVISION DUE TO NECK FRACTURE WAS REQUIRED IN 2025. THIS PATIENT WAS REPORTED TO HAVE A HIGH ACTIVITY LEVEL AND A BMI OF 20.37. THIS IMPLANT LOT WAS MANUFACTURED IN 2022. REVIEW OF THE DESIGN HISTORY RECORD (DHR) FOR THE SUBJECT MANUFACTURING LOT INDICATES THAT THIS IMPLANT WAS MANUFACTURED TO SPECIFICATION. MPO HAS NOT RECEIVED ANY OTHER COMPLAINTS INVOLVING THIS IMPLANT LOT. INVESTIGATION OF TITANIUM MODULAR NECK FRACTURES THROUGH MPO CAPA ACTIONS DETERMINED THE FOLLOWING FINDINGS REGARDING OBSERVED FRACTURE OCCURRENCES: "BASED ON OUR ANALYSIS AND TESTING, WE HAVE IDENTIFIED BOTH PATIENT-RELATED AND SURGICAL-RELATED FACTORS THAT CONTRIBUTE TO THE FRACTURE OF PROFEMUR® MODULAR NECKS. PATIENT-RELATED FACTORS INCLUDE HEAVY WEIGHT AND HIGH LEVELS OF ACTIVITY. SURGICAL-RELATED FACTORS INCLUDE THE ASSEMBLY OF THE MODULAR NECK TO THE STEM AND THE SELECTION OF THE LENGTH OF THE MODULAR NECK/FEMORAL HEAD COMBINATION, TYPICALLY REFERRED TO AS 'OFFSET.' ALTHOUGH RARE, IT IS POSSIBLE THAT STRESSES PRODUCED AT THE MODULAR NECK/STEM TAPER INTERFACE BY HEAVY AND/OR HIGHLY ACTIVE PATIENTS WITH PREDOMINANTLY LONGER OFFSETS CAN EXCEED THE FATIGUE STRENGTH OF THE MODULAR NECK, RESULTING IN FRACTURE. IMPROPER ASSEMBLY OF THE MODULAR NECK TO THE STEM INCREASES THE RISK OF FRACTURE." ADDITIONALLY, MPO HAS COMPLETED A FIELD SAFETY CORRECTIVE ACTION TO REMOVE LONG MODULAR NECKS FROM THE EUROPEAN DISTRIBUTION AS DOCUMENTED THROUGH MPO REFERENCE DISTRIBUTED PRODUCT RISK ASSESSMENT (DPRA). THE CURRENT MICROPORT HIP SYSTEMS PACKAGE INSERT (150803-9) STATES, "FATIGUE FRACTURE OF THE PROSTHETIC COMPONENT CAN OCCUR AS A RESULT OF TRAUMA, STRENUOUS ACTIVITY, IMPROPER ALIGNMENT, INCOMPLETE IMPLANT SEATING, DURATION OF SERVICE, LOSS OF FIXATION, NON-UNION, OR EXCESSIVE WEIGHT." THIS PACKAGE INSERT ALSO STATES, "ALWAYS FOLLOW THE RECOMMENDED SURGICAL TECHNIQUE. FAILURE TO ADHERE TO THE ADVISED ASSEMBLY INSTRUCTIONS MAY HAVE POTENTIAL TO INCREASE RISK OF FRETTING CORROSION, FATIGUE FRACTURE OR DISASSOCIATION OF THE PRODUCT. PRIOR TO ASSEMBLY, SURGICAL DEBRIS AND FLUID MUST BE CLEANED FROM THE INTERIOR OF THE FEMALE SEAT TO ENSURE PROPER LOCKING. ENSURE COMPONENTS ARE FIRMLY SEATED TO PREVENT DISASSOCIATION. THE FEMORAL HEAD, NECK TAPER OF THE FEMORAL COMPONENT, MODULAR NECK TAPERS, BODY TAPER, FEMALE SEAT OF THE PROXIMAL BODY MUST BE CLEAN AND DRY BEFORE ASSEMBLY. IMPACT ACCORDING TO THE RECOMMENDED SURGICAL TECHNIQUE." BASED ON THE AFOREMENTIONED ACTIONS, THIS ISSUE HAS BEEN ADDRESSED. THERE WERE NOT ANY TRENDS IDENTIFIED FOR THIS ITEM AT THE TIME OF THIS COMPLAINT. MPO WILL CONTINUE TO MONITOR FOR THIS ISSUE.