PROFEMUR® MODULAR FEMORAL NECK

Additional Manufacturer Narrative

THE ALLEGED COMPLAINT COULD NOT BE CONFIRMED. THIS PATIENT HAS EXPERIENCED A SECOND REVISION OPERATION. THE REASON FOR THE FIRST REVISION OPERATION IS UNKNOWN, BUT A CERAMIC HEAD AND MODULAR NECK WERE IMPLANTED DURING THE FIRST REVISION THAT TOOK PLACE APPROXIMATELY 94 MONTHS AFTER THE INDEX OPERATION. THE SECOND REVISION OPERATION WAS SCHEDULED TO ADDRESS COMPLICATIONS ASSOCIATED WITH DISLOCATION, AND THIS OPERATION OCCURRED APPROXIMATELY 121 MONTHS AFTER THE PREVIOUS REVISION OPERATION. IN THIS OPERATION, THE SURGEON PLANNED TO REVISE THE ACETABULAR CUP AND POSSIBLY NECK AND FEMORAL HEAD. HOWEVER, IT WAS REPORTED THAT THE CERAMIC LINER COULD NOT BE REMOVED FROM THE ACETABULAR SHELL, AND THE MODULAR NECK COULD NOT BE REMOVED FROM THE FEMORAL STEM. THE SURGEON CHOSE TO REVISE THE CERAMIC HEAD FROM A MEDIUM NECK TO A LONG NECK TO ADDRESS THE DISLOCATION DUE TO THE REPORTED INTRAOPERATIVE COMPLICATIONS. MPO DID NOT RECEIVE ANY PATIENT SPECIFIC DETAILS. MPO HAS NOT RECEIVED ANY RADIOGRAPHIC IMAGES TO EVALUATE COMPONENT POSITIONING. REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE SUBJECT LOTS OF THE FEMORAL HEAD AND MODULAR NECK INDICATES THAT THESE PRODUCTS MET ALL ESTABLISHED ACCEPTANCE CRITERIA THROUGHOUT MANUFACTURING PROCESSES. FURTHERMORE, MPO HAS NOT RECEIVED ANY OTHER COMPLAINT REPORTS INVOLVING THE SUBJECT MANUFACTURING LOTS. THE MANUFACTURING LOT OF THE CERAMIC LINER WAS NOT AVAILABLE. 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 150803-9. REGARDING THE CERAMIC LINER, THIS COMPONENT WAS IMPLANTED IN THE INDEX OPERATION, AND IT WAS REPORTED THAT A CRACK WAS NOTED ON THE RIM OF THE LINER DURING THIS REVISION OPERATION. IT IS UNKNOWN IF THE CRACK COULD HAVE OCCURRED DURING A PREVIOUS SURGERY, FROM PATIENT TRAUMA, OR FROM IMPROPER IMPLANT ALIGNMENT SUCH AS EDGE LOADING THAT COULD HAVE OCCURRED AS A RESULT OF THE REPORTED PATIENT DISLOCATION. MPO HAS NOT IDENTIFIED ANY TRENDS FOR ISSUES REMOVING THIS FAMILY OF CERAMIC LINERS. THE SURGICAL TECHNIQUE OUTLINES THE PROCESS FOR USE OF A LINER EXTRACTOR BY PLACING THE TIP IN A DIMPLE (RECESS FEATURE) IN THE FACE OF THE CUP AND APPLYING SHORT MALLET IMPACTIONS THAT WILL PROVIDE COUNTERACTION LOOSENING OF THE LINER. REPETITIVE ACTION OF THE MALLET STROKES MAY BE NECESSARY. REGARDING THE MODULAR NECK, THIS DEVICE WAS IMPLANTED DURING THE FIRST REVISION OPERATION. THE MODULAR NECK AND FEMORAL STEM MATE VIA A SCRATCH-FIT TAPER THAT CAN BE DIFFICULT TO EXTRACT WITHOUT PROPER INSTRUMENTATION AND TECHNIQUE. AS STATED IN THE SURGICAL TECHNIQUE, "PLEASE NOTE THAT THESE INSTRUMENTS ARE DESIGNED FOR THE PURPOSE OF REMOVING A NECK DURING THE PRIMARY SURGERY. THESE INSTRUMENTS MAY OR MAY NOT BE ABLE TO PROVIDE THE FORCE NECESSARY TO DISENGAGE A CONNECTION BETWEEN COMPONENTS THAT HAVE BEEN IMPLANTED FOR A LONGER PERIOD OF TIME." WHILE THIS OCCURRENCE IS A KNOWN POSSIBLE COMPLICATION, THERE WERE NO TRENDS FOR THIS ISSUE IDENTIFIED AT THE TIME OF THIS COMPLAINT. MPO IS UNABLE TO PROVIDE ANY ADDITIONAL CONCLUSIONS FROM THE AVAILABLE INFORMATION. MPO WILL CONTINUE TO MONITOR FOR THE REPORTED COMPLICATIONS THROUGH COMPLAINT TRACKING.

Description of Event or Problem

DATE OF ORIGINAL SURGERY: ON (B)(6) 2008. DATE OF REVISION SURGERY: ON (B)(6) 2015. ALLEGEDLY, BOTH SURGERIES WERE CONDUCTED AT (B)(6) HOSPITAL DURING THE RE-REVISION SURGERY (3RD SURGERY FOR THE PATIENT) ON (B)(6) 2026 DUE TO DISLOCATION, AN ATTEMPT WAS MADE TO REPLACE THE CUP. HOWEVER, THE NECK AND THE CERAMIC LINER COULD NOT BE EXTRACTED. THE NECK AND THE CERAMIC LINER REMAINED IN THE PATIENT'S BODY. THE 28MM HEAD WAS CHANGED FROM SIZE-M TO L. THE DOCTOR COMMENTED AS FOLLOWS; CHANGING THE 28MM HEAD FROM SIZE M (26000005) TO L(PHA04406), THE CORRESPONDING INCREASE IN DISLOCATION RESISTANCE WAS ACHIEVED. A CRACK WAS NOTED ON THE RIM OF THE CERAMIC LINER, BUT REMOVAL WAS NOT POSSIBLE. ACCORDING TO THE NEW INFORMATION RECEIVED ON 02/13/2026, THE PART PPR67508 WAS IMPLANTED DURING THE ORIGINAL SURGERY (ON (B)(6) 2008) AND EXPLANTED DURING THE REVISION ON (B)(6) 2026). THE OTHER TWO PARTS REPORTED WERE USE IN THE SECOND SURGERY IN 2015 (B)(6).

Additional Manufacturer Narrative

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