POLARCUP SHELL TI-PLASMA/HA 55 NON-CEM

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B2 (OUTCOMES ATTRIBUTED TO AE), B3 (OCCURRENCE DATE), H6 (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS). RESULTS OF INVESTIGATION: IT WAS REPORTED THAT, AFTER A TOTAL HIP REPLACEMENT HAD BEEN PERFORMED ON AN UNKNOW DATE, THERE WAS PRESENCE OF HEAVY METALLOSIS CAUSED BY THE DISLOCATION OF THE CERAMIC HEAD. A REVISION SURGERY WAS PERFORMED IN (B)(6) 2024 (EXACT DATE UNKNOWN), IN WHICH ONE (1) POLARCUP SHELL TI-PLASMA/HA 55 NON-CEM AND ONE (1) POLARCUP PE INSERT 55/28 NON-CEM WERE EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. NO VISUAL INSPECTION COULD BE PERFORMED. A REVIEW OF THE PRODUCT 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 NO 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. A REVIEW OF THE DEVICE LABELING REVEALED THAT THE IFU (LIT. NO. 81113832 REV. 0) STATES METAL RELATED PATHOLOGY OF THE COMPONENT 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 COMPLAINT CANNOT BE CONFIRMED. THE ROOT CAUSE OF THE DISLOCATION OF THE CERAMIC HEAD REMAINS UNDETERMINED. IT IS SUSPECTED THAT AN OFF-LABEL USE CONTRIBUTED TO THE REPORTED EVENT AS IT HAS BEEN REPORTED THAT A DEVICE FROM A DIFFERENT MANUFACTURER IS INVOLVED. AS ONLY THE SHELL AND SHELL INSERT WERE EXPLANTED, IT IS SUSPECTED THAT EITHER THE INITIALLY IMPLANTED BALL HEAD OR HIP STEM IS NOT FROM SMITH AND NEPHEW AS PER TOTAL HIP REPLACEMENT THE HIP JOINT WILL BE REPLACED AND CONSISTS OF AT LEAST A HIP CUP, BALL HEAD AND HIP STEM. HENCE, THE RETURNED SMITH AND NEPHEW ARTICLES ARE SUSPECTED TO HAVE BEEN PAIRED WITH PRODUCTS FROM A DIFFERENT MANUFACTURER. WE ADVISE TO FOLLOW OUR PRODUCT COMPATIBILITIES (HTTPS://WWW.SMITH-NEPHEW.COM/EN-US/PRODUCT-COMPATIBILITY) FOR APPROVED AND ALLOWED COMBINATIONS. THE NEED FOR FURTHER ACTIONS IS NOT INDICATED. 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. THIS INVESTIGATION IS CONSIDERED CLOSED.

Description of Event or Problem

IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON AN UNKNOW DATE, THERE WAS PRESENCE OF HEAVY METALLOSIS CAUSED BY THE DISLOCATION OF THE CERAMIC HEAD. A REVISION SURGERY WAS PERFORMED IN (B)(6) 2024 (EXACT DATE UNKNOWN), IN WHICH ONE (1) POLARCUP SHELL TI-PLASMA/HA 55 NON-CEM AND ONE (1) POLARCUP PE INSERT 55/28 NON-CEM WERE EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE: (B)(4).