POLARSTEM STEM STD TI/HA 2 NON-CEM

Description of Event or Problem

IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED SEPTIC SOCKET LOOSENING. THIS ADVERSE EVENT WAS RESOLVED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE POLARSTEM STEM STD TI/HA 2 NON-CEM AND THE POLARCUP XLPE INSERT 51/28 NON-CEM WERE EXCHANGED. THE PATIENT IS INDEPENDENTLY MOBILE WITH TWO WALKING STICKS.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE (B)(4).

Additional Manufacturer Narrative

SECTION D10 WAS UPDATED. SECTION H10: IT WAS REPORTED THAT, AFTER A TOTAL HIP REPLACEMENT SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED ACETABULAR PROTRUSION AND FEMORAL STEM SUBSIDENCE DUE TO PROSTHESIS LOOSENING. THIS ADVERSE EVENT WAS RESOLVED BY A REVISION SURGERY ON (B)(6) 2024. DURING THIS PROCEDURE, ALL THE TOTAL HIP REPLACEMENT SYSTEM COMPONENTS WERE EXPLANTED. THE PATIENT IS INDEPENDENTLY MOBILE WITH TWO WALKING STICKS. THIS INVESTIGATION REFERS TO THE COMPLAINT SAMPLE POLARSTEM STEM STD TI/HA 2 NON-CEM. THE COMPLAINT DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL EVALUATION OF THE DEVICE WAS CONDUCTED, AND IT WAS CONCLUDED THAT THERE ARE SLIGHT SIGNS OF OSSEOINTEGRATION SUCH AS DEPOSITS OF BONE MATERIAL ARE VISIBLE AROUND THE WHOLE ROUGH SURFACE OF THE STEM. ADDITIONALLY, SCRATCHES AND DENTS ON BOTH SIDES OF THE PROXIMAL END OF THE STEM ARE VISIBLE. THESE SCRATCHES POTENTIALLY AROSE FROM A CLAMP DURING STEM EXTRACTION. DISCOLORED AREAS AT THE PROXIMAL STEM END ARE POTENTIALLY ORIGINATING FROM THE ELECTRO SCALPEL DURING STEM EXTRACTION. A REVIEW OF THE PRODUCTION DOCUMENTATION DID NOT DETECT ANY DEVIATION THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE COMPLAINT HISTORY REVIEW FOR THE COMPLAINT DEVICE REVEALED NO ADDITIONAL COMPLAINTS FOR THE AFFECTED BATCH NOR ADDITIONAL COMPLAINTS FOR THE SAME PRODUCT NUMBER OVER THE PAST 12 MONTHS WITH SIMILAR FAILURE MODE. A REVIEW OF PAST CORRECTIVE ACTIONS WAS PERFORMED. NO FURTHER ESCALATION IS REQUIRED. A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION VERIFIES THE FAILURE MODE, OCCURRENCE AND SEVERITY OF THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE STATES INADEQUATE OSSEOINTEGRATION AND MIGRATION OF DEVICE AS RESULTING FROM A HIP ARTHROPLASTY. BASED ON THE PROVIDED TRANSLATED OPERATIVE NOTES AND (B)(4) REPORT, ACETABULAR PROTRUSION AND FEMORAL STEM SUBSIDENCE WITH LEG LENGTH DIFFERENCE IN THE EARLY POSTOP COURSE SECONDARY TO PROSTHETIC LOOSENING LED TO THE LEFT HIP REVISION JUST 11 DAYS POST IMPLANTATION, ALTHOUGH THE PRODUCT EVALUATION/VISUAL INSPECTION REPORTED ¿FIGURE 2: SIGNS OF OSSEOINTEGRATION (DEPOSITS OF BONE MATERIAL) ARE VISIBLE AROUND THE WHOLE ROUGH SURFACE OF THE STEM.¿ THE PATIENT IMPACT INCLUDED THE REPORTED SYMPTOMS, INTRAOPERATIVE FINDINGS/EARLY REVISION TO COMPETITOR COMPONENTS, AND POST-OPERATIVE RESTORATIVE PHASE USING THE REPORTED AMBULATORY ASSIST DEVICE(S). THERE IS NO INDICATION THAT THE REPORTED DEVICE FAILED TO MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. BASED ON THE AVAILABLE INFORMATION AND THE PERFORMED INVESTIGATION, THE COMPLAINT CAN BE CONFIRMED. THE ROOT CAUSE OF THE REPORTED EVENT REMAINS UNDETERMINED. THE NEED FOR FURTHER ACTIONS IS NOT INDICATED. NEVERTHELESS, SMITH+NEPHEW WILL CONTINUE TO MONITOR THIS DEVICE FOR SIMILAR ISSUES. THE RETURNED DEVICE WILL BE RETAINED. INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D10 (FEMORAL HEAD ADDED AS CONCOMITANT PRODUCT). CORRECTED DATA: B5 (NARRATIVE), H6 (HEALTH EFFECT - CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE).

Description of Event or Problem

IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED ACETABULAR PROTRUSION AND FEMORAL STEM SUBSIDENCE DUE TO PROSTHESIS LOOSENING. THIS ADVERSE EVENT WAS RESOLVED BY A REVISION SURGERY ON (B)(6) 2024. DURING THIS PROCEDURE, ALL THE THR SYSTEM COMPONENTS WERE EXPLANTED. THE PATIENT IS INDEPENDENTLY MOBILE WITH TWO WALKING STICKS.