PROFEMUR® MODULAR FEMORAL NECK

Additional Manufacturer Narrative

THE ALLEGED COMPLAINT COULD NOT BE CONFIRMED. MPO WAS MADE AWARE OF THIS REVISION DUE TO POSSIBLE DISLOCATION THAT OCCURRED APPROXIMATELY 94 MONTHS AFTER THE INDEX OPERATION. THIS INCIDENT GROUP CAPTURES THE FIRST REVISION OPERATION FOR THIS PATIENT THAT OCCURRED IN 2015 WITH SECOND REVISION OPERATION OCCURRING IN 2026 (INCIDENT GROUP (B)(4)). BASED ON THE PROVIDED INFORMATION, THE PATIENT HAS EXPERIENCED MULTIPLE DISLOCATIONS. DURING THE FIRST REVISION, THE MODULAR NECK AND FEMORAL HEAD WERE REPLACED. MPO HAS NOT RECEIVED ANY RADIOGRAPHIC IMAGES TO EVALUATE COMPONENT POSITIONING. THE LOT INFORMATION FOR THE DEVICES IMPLANTED IN THE INDEX OPERATION IS NOT AVAILABLE. THEREFORE, THE DEVICE HISTORY RECORD (DHR) CANNOT BE REVIEWED FOR THE COMPLAINT DEVICES, AND LOT TRENDING IS NOT POSSIBLE FOR THIS COMPLAINT. REGARDING THE REPORTED DISLOCATION, BOTH PATIENT AND SURGICAL FACTORS COULD CONTRIBUTE TO DISLOCATION BASED ON POSSIBLE CHANGES IN IMPLANT ALIGNMENT AND/OR PROGRESSIVE TISSUE LAXITY. THESE POSSIBLE ADVERSE EFFECTS ARE REPORTED IN THE MPO HIP SYSTEMS PACKAGE INSERT, DOCUMENT REFERENCE (B)(4). MPO IS UNABLE TO PROVIDE ANY ADDITIONAL CONCLUSIONS FROM THE AVAILABLE INFORMATION. THERE WERE NO TRENDS FOR DISLOCATION IDENTIFIED FOR THESE PRODUCT FAMILIES AT THE TIME OF THIS COMPLAINT. MPO WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS THROUGH COMPLAINT TRACKING.

Description of Event or Problem

ALLEGEDLY, THE EVENT OCCURRED IN THE SAME PATIENT AS (B)(6)/ INCIDENT NO. (B)(4). THE PATIENT IMPLANTED MPO PRODUCTS DURING PRIMARY SURGERY ON (B)(6) 2008 AND UNDERWENT REVISION SURGERY ON (B)(6) 20215. WE WERE UNABLE TO OBTAIN THE ATTENDING DOCTOR'S COMMENTS FROM 2015. INSTEAD, WE RECEIVED (B)(6) TO US), WHERE THE PATIENT UNDERWENT A THIRD SURGERY IN 2026, SUGGESTING THAT THE REVISION SURGERY MAY HAVE BEEN DUE TO DISLOCATION. THE PRODUCTS USED IN THE INITIAL SURGERY (IN 2008) FOR THE PATIENT. (B)(6). THE PRODUCTS USED IN THE SECOND SURGERY (IN 2015) FOR THE PATIENT: # (B)(6) (LOT#14852501575878), # (B)(6)(LOT#15374101619171). ADDITIONAL INFORMATION RECEIVED ON 03/19/2026 FROM THE RE DEPARTMENT: DUE TO DISLOCATION THE COMPONENTS EXPLANTED ON THE FIRST REVISION (2015) WERE THE NECK AND HEAD (B)(4)