PROFEMUR® MODULAR FEMORAL NECK

Additional Manufacturer Narrative

THE ALLEGED COMPLAINT COULD NOT BE CONFIRMED. THIS 60-YEAR-OLD MALE PATIENT EXPERIENCED A FRACTURE OF THE LONG STRAIGHT MODULAR NECK, MODEL NUMBER PHA01204. THE REVISION OPERATION OCCURRED APPROXIMATELY 192 MONTHS AFTER THE INDEX OPERATION. THE PATIENT WAS NOTED TO BE 170CM TALL AND 80KG IN WEIGHT. THE PATIENT WAS ALSO DESCRIBED AS HAVING HIGH ACTIVITY LEVEL. THE EXPLANTED PRODUCTS HAVE NOT BEEN RETURNED TO MPO FOR EVALUATION. FURTHERMORE, MPO HAS NOT RECEIVED RADIOGRAPHS, IMAGES, OPERATIVE NOTES, OR OTHER CLINICALLY RELEVANT DOCUMENTATION FOR INVESTIGATION. THE LOT NUMBERS OF THE SUBJECT DEVICES WAS NOT PROVIDED TO MPO BY THE REPORTING PERSON. THEREFORE, THE DEVICE HISTORY RECORDS (DHRS) CANNOT BE REVIEWED, NOR CAN LOT TRENDING BE PERFORMED. INVESTIGATION OF TITANIUM MODULAR NECK FRACTURES THROUGH MPO CAPA ACTIONS 172 AND 370 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 TITANIUM NECKS FROM AUSTRALIA AS DOCUMENTED THROUGH MPO REFERENCE DISTRIBUTED PRODUCT RISK ASSESSMENT (DPRA) #(B)(4). THE CURRENT MICROPORT HIP SYSTEMS PACKAGE INSERT (B)(6) 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." THIS ISSUE HAS BEEN ADDRESSED THROUGH THE AFOREMENTIONED CAPA AND DPRA ACTIONS. THERE WERE NOT ANY TRENDS IDENTIFIED FOR THIS ITEM AT THE TIME OF THIS COMPLAINT. MPO WILL CONTINUE TO MONITOR FOR THIS ISSUE.

Additional Manufacturer Narrative

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

Description of Event or Problem

ALLEGEDLY, MODULAR NECK FRACTURE.