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, BREAKAGE OF THE NECK.

Additional Manufacturer Narrative

THE ALLEGED COMPLAINT IS CONFIRMED. MPO RECEIVED THE DISTAL FRACTURE REMNANT OF THE COMPLAINT DEVICE. VISUAL REVIEW OF THE RETURNED REMNANT CONFIRMS A TRANSVERSE FATIGUE FRACTURE. THE SUBJECT LOT COMPLETED THE MANUFACTURING PROCESS IN 2005. THE DATE OF IMPLANTATION IS UNKNOWN, BUT THE IMPLANT WOULD HAVE BEEN IMPLANTED FOR MORE THAN 14 YEARS DUE TO HAVING AN EXPIRATION DATE IN 2010. MPO DID NOT RECEIVE ANY RADIOGRAPHIC IMAGES TO EVALUATE IMPLANT ALIGNMENT OR FIXATION. INVESTIGATION OF TITANIUM MODULAR NECK FRACTURES THROUGH MPO CAPA 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." LONG AND X-LONG MODULAR NECKS HAVE SINCE BEEN VOLUNTARILY RECALLED IN THE REPORTING COUNTRY 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." THE CURRENT PACKAGE INSERT ALSO WARNS AGAINST USE OF PROFEMUR TITANIUM MODULAR NECKS IN PATIENTS WITH ELEVATED WEIGHT, STATING THE FOLLOWING: "HIGHER THAN NORMAL RATES OF EARLY FAILURE OF THE LONG OFFSET PROFEMUR® TITANIUM MODULAR NECKS HAVE BEEN OBSERVED FOR HEAVYWEIGHT (>230 LBS) PATIENTS. THIS SHOULD BE CONSIDERED IN PATIENT SELECTION WHEN USING A TITANIUM MODULAR NECK. OTHER PATIENT SELECTION FACTORS SUCH AS ACTIVITY LEVEL CANNOT BE DISMISSED AS POTENTIAL FACTORS IN THESE FAILURES. ALTERNATIVE DEVICES, SUCH AS COBALT CHROME MODULAR NECKS AND MONOBLOCK HIP STEMS, MAY ALSO BE CONSIDERED FOR THESE PATIENTS." THERE WERE NOT ANY TRENDS IDENTIFIED FOR THIS ITEM AND FAILURE PER MPO TRENDING PROCEDURES. NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. MPO WILL CONTINUE TO MONITOR THIS FAILURE TYPE THROUGH COMPLAINT TRACKING.