PROFEMUR® ROUGHENED DISTAL STEM, TAPERED

Additional Manufacturer Narrative

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

Description of Event or Problem

ALLEGEDLY A SURGERY INDICATION WAS GIVEN TO PERFORM THE REPLACEMENT OF A RIGHT PTH THAT HAS BROKEN IN THE PATIENT.

Additional Manufacturer Narrative

THE ALLEGED COMPLAINT IS CONFIRMED. VISUAL REVIEW OF PROVIDED IMAGES AND EVALUATION OF THE EXPLANTED DEVICES CONFIRMS THAT THE PROFEMUR R BOWED DISTAL STEM, PPW38023, HAS FRACTURED. THE FRACTURE IS LOCATED IN THE PROXIMAL REGION, NEAR THE TAPER JUNCTION BETWEEN THE DISTAL STEM AND THE PROXIMAL BODY. MPO WAS NOT MADE AWARE OF THE DATE OF IMPLANTATION, NOR WERE ANY PATIENT SPECIFIC DETAILS PROVIDED. ASIDE FROM TWO IMAGES OF THE EXPLANTED PRODUCTS, MPO DID NOT RECEIVE ANY OTHER SUPPLEMENTARY DOCUMENTATION SUCH AS RADIOGRAPHIC IMAGES OR OPERATIVE NOTES. THE MANUFACTURING LOT FOR THE PROFEMUR R PROXIMAL BODY, PPW39130 LOT: 079879883, COMPLETED THE MANUFACTURING PROCESS IN 2009, AND THE PROFEMUR R DISTAL STEM, PPW38023 LOT: 1549394, COMPLETED THE MANUFACTURING PROCESS IN 2014. THEREFORE, BASED ON MANUFACTURING AND EXPIRATION DATES FOR THE SUBJECT DEVICES, IT IS LIKELY THAT THESE PRODUCTS COULD HAVE BEEN IMPLANTED FOR APPROXIMATELY 7-10 YEARS PRIOR TO THE FRACTURE OCCURRENCE. MPO HAS NOT RECEIVED ANY OTHER COMPLAINTS INVOLVING THE SUBJECT MANUFACTURING LOTS. THERE WERE NOT ANY TRENDS IDENTIFIED FOR FRACTURE INVOLVING PROFEMUR STEMS AT THE TIME OF THIS COMPLAINT. PHOTOGRAPHIC AND MICROSCOPIC EVALUATION OF THE FRACTURED IMPLANT APPEARS TO REVEAL A TRANSVERSE FATIGUE FRACTURE. THE FRACTURE SURFACE IS POSSIBLY CONSISTENT WITH AN IMPLANT THAT COULD HAVE EXPERIENCED HIGH STRESSES IN THE FRACTURE REGION FROM CYCLIC LOADING. MPO DID NOT RECEIVE ANY RADIOGRAPHIC IMAGES TO EVALUATE IMPLANT FIXATION. THE RETURNED IMPLANTS DID NOT HAVE EVIDENCE OF BONE CEMENT AND/OR TISSUE ADHERENCE ON THE ROUGHENED SURFACE. A SMALL AMOUNT OF BONE TISSUE WAS WITNESSED IN THE DISTAL REGION OF THE STEM, BUT NO TISSUE WAS PRESENT IN THE REGION OF THE FRACTURE. THEREFORE, IT IS POSSIBLE THAT THE IMPLANT MAY HAVE NOT BEEN ADEQUATELY SUPPORTED. VARIOUS FACTORS INCLUDING PATIENT BMI, ACTIVITY LEVEL, SELECTION OF IMPLANTS, TECHNIQUE, IMPLANT POSITIONING, AND QUALITY FIXATION CAN AFFECT PRODUCT PERFORMANCE IN VIVO. THE CURRENT MICROPORT HIP SYSTEMS PACKAGE INSERT (150803-9) LISTS IMPLANT FRACTURE AS A POSSIBLE ADVERSE EFFECT OF TOTAL HIP ARTHROPLASTY: "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, "THE PATIENT MUST BE ADVISED OF THE LIMITATIONS OF THE RECONSTRUCTION AND THE NEED FOR PROTECTION OF THE PROSTHESIS FROM FULL WEIGHT BEARING UNTIL ADEQUATE FIXATION AND HEALING HAVE OCCURRED. THE PATIENT SHOULD BE CAUTIONED TO LIMIT ACTIVITIES AND PROTECT THE REPLACED JOINT FROM UNREASONABLE STRESSES AND POSSIBLE LOOSENING, FRACTURE AND/OR WEAR, AND FOLLOW THE INSTRUCTIONS OF THE PHYSICIAN WITH RESPECT TO FOLLOW-UP CARE AND TREATMENT. LOOSENING OF THE COMPONENTS CAN RESULT IN INCREASED PRODUCTION OF WEAR PARTICLES, AS WELL AS DAMAGE TO THE BONE, MAKING SUCCESSFUL REVISION SURGERY MORE DIFFICULT. PERIODIC, LONG-TERM FOLLOW-UP IS RECOMMENDED TO MONITOR THE POSITION AND STATE OF THE PROSTHETIC COMPONENTS, AS WELL AS THE CONDITION OF THE ADJOINING BONE. PERIODIC POST-OPERATIVE X-RAYS ARE RECOMMENDED FOR CLOSE COMPARISON WITH EARLY POST-OP CONDITIONS TO DETECT LONG TERM EVIDENCE OF CHANGES IN POSITION, LOOSENING, BENDING, OR CRACKING OF COMPONENTS." HOWEVER, WITHOUT ADDITIONAL DETAILS REGARDING THIS EVENT OR RECEIPT OF RADIOGRAPHIC IMAGES, MPO IS UNABLE TO PROVIDE ANY CONCLUSIONS REGARDING POSSIBLE CAUSE OF THE FRACTURE OCCURRENCE. THERE WERE NO TRENDS OBSERVED. MPO WILL CONTINUE TO MONITOR THIS COMPLAINT ISSUE THROUGH COMPLAINT TRACKING. METHODS: TESTING OF ACTUAL/SUSPECTED DEVICE (10). ANALYSIS OF PRODUCTION RECORDS (3331). TREND ANALYSIS (4110). RESULTS: FRACTURE PROBLEM (3252). CONCLUSIONS: DEVICE MET SPECIFICATION. DEVICE WAS USED FOR TREATMENT. CAUSE NOT ESTABLISHED (4315). KNOWN INHERENT RISK OF DEVICE (22). CORRECT TYPE OF REPORTABLE EVENT: SERIOUS INJURY.