POLARSTEM STEM STD TI/HA 4 NON-CEM

Additional Manufacturer Narrative

H10: INTERNAL COMPLAINT REFERENCE: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2023, THE PATIENT ADMITTED WITH QUERY PAIN IN HIP AND X-RAY INDICATED SUBSIDENCE OF FEMORAL STEM. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 AND, UPON OPENING THE JOINT, SURGEON FOUND SIGNS OF PUS, WHICH INDICATED SEPSIS. THE IMPLANTS WERE SUBSEQUENTLY REMOVED AND CEMENT SPACER USED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

Additional Manufacturer Narrative

IT WAS REPORTED THAT, AFTER A TOTAL HIP REPLACEMENT SURGERY PERFORMED ON (B)(6) 2023, THE PATIENT ADMITTED WITH QUERY PAIN IN HIP AND X-RAY INDICATED SUBSIDENCE OF FEMORAL STEM. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 AND, UPON OPENING THE JOINT, SURGEON FOUND SIGNS OF PUS, WHICH INDICATED SEPSIS. THE IMPLANTS WERE SUBSEQUENTLY REMOVED AND CEMENT SPACER USED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. THE EXPLANTED DEVICES USED IN TREATMENT WERE NOT RETURNED FOR INVESTIGATION. A PRODUCT EVALUATION WAS NOT POSSIBLE. A REVIEW OF THE PRODUCTION DOCUMENTATION OF THE POLARSTEM AND THE CONCOMITANTS DID NOT DETECT ANY DEVIATION THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE REVIEW OF HISTORICAL COMPLAINTS FOR THE ALLEGED DEVICE AND THE CONCOMITANTS REVEALED NO ADDITIONAL SIMILAR COMPLAINTS REPORTED FOR THE INVOLVED BATCHES. THE REVIEW OF HISTORICAL COMPLAINTS FOR THE ALL THE INVOLVED DEVICES REVEALED ONLY 2 ADDITIONAL SIMILAR COMPLAINTS FOR THE FEMORAL HEAD PART NUMBER OVER THE PAST 12 MONTHS WITH SIMILAR FAILURE MODE, WHILE THE OTHER DEVICES SHOWED NO RESULTS. 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 INFECTION 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. DUE TO INSUFFICIENT INFORMATION, IT IS NOT POSSIBLE TO INDICATE FACTORS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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.