POLARSTEM COLLAR STD. TI/HA 2

Description of Event or Problem

IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2024, WHERE THE IMPLANTED STEM WAS UNDERSIZED, THE PATIENT EXPERIENCED PERIPROSTHETIC FRACTURE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A POLARSTEM COLLAR STD. TI/HA 2 WAS EXCHANGED WITH A REDAPT STEM AND CABLE. PATIENT LEFT SURGERY IN GOOD HEALTH. NO FURTHER COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

CORRECTED DATA: B5, H6 (MEDICAL DEVICE PROBLEM CODE).

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE: (B)(4). THE COMPLAINT SAMPLE WAS NOT RETURNED. NO PRODUCT EVALUATION COULD BE PERFORMED. THE REVIEW OF HISTORICAL COMPLAINTS FOR THE ALLEGED DEVICE REVEALED NO ADDITIONAL SIMILAR COMPLAINTS REPORTED FOR THE SAME BATCH, AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE SAME PRODUCT NUMBER OVER THE PAST 12 MONTHS WITH SIMILAR FAILURE MODE. A REVIEW OF THE PRODUCT DOCUMENTATION DID NOT DETECT ANY DEVIATION THAT COULD HAVE CONTRIBUTED TO THE REPORTED 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. A REVIEW OF THE DEVICE LABELING REVEALED THAT THE IFU (81114321 REV. A) STATES BONE FRACTURE(S) AS A ¿POTENTIAL ADVERSE DEVICE EFFECT¿ IN COMBINATION WITH THE IMPLANTATION OF A HIP PROSTHESIS. BASED ON THE AVAILABLE INFORMATION AND THE PERFORMED INVESTIGATION, THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE CANNOT BE CONFIRMED. DUE TO INSUFFICIENT INFORMATION, IT IS NOT POSSIBLE TO SPECULATE ABOUT FACTORS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE REPORTED EVENT REMAINS THEREFORE UNDETERMINED. THE NEED FOR FURTHER ACTIONS IS NOT INDICATED. THIS INVESTIGATION IS CONSIDERED CLOSED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. SMITH AND NEPHEW WILL CONTINUE TO MONITOR THIS DEVICE FOR SIMILAR ISSUES.

Description of Event or Problem

IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED PERIPROSTHETIC FRACTURE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A POLARSTEM COLLAR STD. TI/HA 2 WAS EXCHANGED WITH A REDAPT STEM AND CABLE. PATIENT LEFT SURGERY IN GOOD HEALTH. NO FURTHER COMPLICATIONS WERE REPORTED.