POLARSTEM STEM STD TI/HA 3 NON-CEM

Additional Manufacturer Narrative

H3, H6: IT WAS REPORTED THAT, AFTER A TOTAL HIP REPLACEMENT SURGERY WAS PERFORMED FOR A RIGHT FEMORAL NECK FRACTURE, THE PATIENT FELL AND INJURED HIS RIGHT HIP, CAUSING PAIN, SWELLING AND LIMITED MOVEMENT OF THE RIGHT HIP. FURTHERMORE, AN X-RAY WAS PERFORMED, WHICH SHOWED POSITIVE AND LATERAL HIP JOINT (RIGHT), AND A RIGHT PROXIMAL FEMUR FRACTURE. THIS ADVERSE EVENT WAS TREATED VIA REVISION SURGERY IN WHICH A POLARSTEM STEM STD TI/HA 3 NON-CEM, THE OXINIUM FEM HD 12/14 28MM +0 AND THE TANDEM INTL BIPOLAR 46OD 28ID WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. THE DEVICE USED IN TREATMENT WAS NOT RETURNED FOR INVESTIGATION. A PRODUCT EVALUATION WAS NOT POSSIBLE. A REVIEW OF THE PRODUCTION DOCUMENTATION DID NOT DETECT ANY DEVIATION THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE REVIEW OF HISTORICAL COMPLAINTS FOR THE ALLEGED DEVICE REVEALED NO ADDITIONAL SIMILAR COMPLAINTS REPORTED FOR THE SAME BATCH, AND 15 ADDITIONAL SIMILAR 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 (LIT. NO. 12.23, ED 03/21) STATES "HIP FRACTURE", "SWELLING", "PAIN" OF THE COMPONENT AS A ¿POTENTIAL ADVERSE DEVICE EFFECT¿ RESULTING FROM A HIP ARTHROPLASTY. NO CLINICALLY SUFFICIENT DATA WAS PROVIDED TO PERFORM A MEDICAL INVESTIGATION. THE PERFORMED INVESTIGATION DOES NOT LEAD TO AN ACCURATELY DETERMINED CAUSE. THERE IS NO EVIDENCE THAT THE REPORTED DEVICES FAILED TO MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. SPECIFIC FACTORS KNOWN TO CONTRIBUTE TO A BONE FRACTURE ARE PHYSICAL ACTIVITY LEVELS, UNREASONABLE STRESS ON REPLACEMENT SYSTEM, AND TRAUMA TO THE JOINT REPLACEMENT. ALL OF THESE MAY LEAD TO AN ACCIDENTAL FALL AND SO MUST BE AVOIDED AFTER A TOTAL HIP REPLACEMENT SURGERY. THERE IS NO NEED FOR FURTHER ACTIONS BECAUSE OF THE LIMITED INFORMATION PROVIDED. NEVERTHELESS, SMITH + NEPHEW WILL CONTINUE TO MONITOR THIS DEVICE FOR SIMILAR ISSUES. THIS COMPLAINT WILL BE REOPENED SHOULD ADDITIONAL INFORMATION OR THE DEVICE BE RECEIVED.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2021 FOR A RIGHT FEMORAL NECK FRACTURE, ON (B)(6) 2023 THE PATIENT FELL AND INJURED HIS RIGHT HIP, CAUSING PAIN, SWELLING AND LIMITED MOVEMENT OF THE RIGHT HIP. FURTHERMORE, AN X-RAY WAS PERFORMED ON (B)(6) 2023, WHICH SHOWED POSITIVE AND LATERAL HIP JOINT (RIGHT), AND A RIGHT PROXIMAL FEMUR FRACTURE. THE PATIENT WAS TREATED IN THE EMERGENCY DEPARTMENT OF THE HOSPITAL WITH EXTERNAL VOTALIN APPLICATION, PAIN RELIEF, AND BED REST. THEN, ON (B)(6) 2023, THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH THE POLARSTEM STEM STD TI/HA 3 NON-CEM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.