PROFEMUR® MODULAR FEMORAL NECK

Additional Manufacturer Narrative

THE ALLEGED COMPLAINT COULD NOT BE CONFIRMED. MPO RECEIVED INFORMATION THAT INDICATES THIS MALE PATIENT UNDERWENT REVISION ON BOTH THE LEFT AND RIGHT HIP ARTHROPLASTY CONSTRUCTS. THE FILE ALLEGES THAT THE PATIENT EXPERIENCED FRACTURE OF THE MODULAR NECK ON THE RIGHT SIDE, WHICH IS CAPTURED BY INCIDENT GROUP (B)(4). THIS GROUP IS INVESTIGATING THE REVISION OF THE LEFT HIP ARTHROPLASTY. HOWEVER, THERE WERE NOT A SPECIFIC DEVICE FAILURE OR COMPLICATIONS STATED AGAINST THE LEFT HIP ARTHROPLASTY. THE PATIENT HAS METAL-ON-METAL ARTICULATION FOR THE LEFT HIP ARTHROPLASTY DEVICES. THEREFORE, INVESTIGATION OF THE ARTICULATING DEVICE IS ADDRESSED THROUGH MPO DOCUMENT (B)(4) COMPLAINT INVESTIGATION OF METAL-ON-METAL HIP IMPLANTS. THE REMAINDER OF THIS INVESTIGATION WILL FOCUS ON THE OTHER IMPLANTS. THE IMPLANTS OF THE LEFT HIP ARTHROPLASTY WERE REVISED SHORTLY AFTER THE RIGHT HIP REVISION OPERATION, WHICH WAS APPROXIMATELY 183 MONTHS AFTER THE INDEX OPERATION. THE EXPLANTED PRODUCTS HAVE NOT BEEN RETURNED TO MPO FOR INVESTIGATION, AND MPO HAS NOT RECEIVED IMAGES, RADIOGRAPHS, OPERATIVE NOTES, OR ANY OTHER CLINICALLY RELEVANT DOCUMENTATION TO CONFIRM A COMPLAINT AGAINST THE DEVICES OF THE LEFT HIP. REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE SUBJECT MANUFACTURING LOTS INDICATES THAT THESE PRODUCTS MET ALL ESTABLISHED ACCEPTANCE CRITERIA THROUGHOUT MANUFACTURING PROCESSES. FURTHERMORE, THERE WERE NOT ANY LOT TRENDS IDENTIFIED. THERE IS INSUFFICIENT INFORMATION AVAILABLE TO INVESTIGATE A COMPLAINT AGAINST THE LEFT HIP ARTHROPLASTY DEVICES. MPO WILL REOPEN THE INVESTIGATION IF NEW DETAILS ARE RECEIVED.

Additional Manufacturer Narrative

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

Description of Event or Problem

ALLEGEDLY, PLAINTIFF WILL BE CAUSED TO UNDERGO A LEFT TOTAL HIP REPLACEMENT WITH RESULTING SCARRING TO REMOVE THE DEFECTIVE HIP IMPLANT.