HEMICAP ARTHROPLASTY SYSTEM PROSTHESIS

Description of Event or Problem

THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ANIKA OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ANIKA, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. ON (B)(6) 2024, IT WAS REPORTED TO ARTHROSURFACE THAT 53-YEAR-OLD MALE PATIENT REPORTED TO THE PHYSICIAN REPORTING MILD TO MODERATE RELIEF AFTER RECEIVING A PATELLA FEMORAL ARTHROPLASTY ON OR ABOUT (B)(6) 2022. DATE OF INITIAL IMPLANT WAS NOT REPORTED. THE FOLLOWING WEEK THE PATIENT RECEIVED AN X-RAY. THE X-RAY SHOWS A SEPARATION OF THE PETELLA COMPONENT FROM THE TAPER POST OF THE SYSTEM. THE PATIENT DENIED ANY TRAUMA OR IMPACT THAT COULD HAVE CONTRIBUTED TO THE FAILURE. THE PATIENT CANCELLED THE REVISION PROCEDURE THAT WAS SCHEDULED FOR (B)(6) 2024. ADDITIONAL INFORMATION WAS SOLICITED.

Additional Manufacturer Narrative

THIS CASE IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR UPON COMPLETION OF THE INVESTIGATION BY THE MANUFACTURING PLANT. SUPPLEMENTAL REPORT: THE REPORTED EVENT IS CONFIRMED BASED ON X-RAYS PROVIDED. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS NOT PROVIDED UPON REQUEST, AND IT WAS REPORTED THAT THE PATIENT CANCELLED THE SCHEDULED REVISION PROCEDURE TO SEEK ANOTHER OPINION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED. THERE WAS NO NON-CONFORMANCES DOCUMENTED IN THE REPORT. THE PRODUCT WAS MANUFACTURED AND RELEASED TO APPLICABLE PROCEDURES AND SPECIFICATIONS. A THREE-YEAR RETROSPECTIVE REVIEW OF ALL NON-CONFORMANCES FOR THIS PRODUCT WAS PERFORMED. THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED AND TRENDED FOR FUTURE ANALYSIS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION.

Description of Event or Problem

THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ANIKA OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ANIKA, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. ON 17APRIL2024 IT WAS REPORTED TO ARTHROSURFACE THAT 53-YEAR-OLD MALE PATIENT REPORTED TO THE PHYSICIAN REPORTING MILD TO MODERATE RELIEF AFTER RECEIVING A PATELLA FEMORAL ARTHROPLASTY ON OR ABOUT (B)(6) 2022. DATE OF INITIAL IMPLANT WAS NOT REPORTED. THE FOLLOWING WEEK THE PATIENT RECEIVED AN X-RAY. THE X-RAY SHOWS A SEPERATION OF THE PETELLA COMPONENT FROM THE TAPER POST OF THE SYSTEM. THE PATIENT DENIED ANY TRAUMA OR IMPACT THAT COULD HAVE CONTRIBUTED TO THE FAILURE. THE PATIENT CANCELLED THE REVISION PROCEDURE THAT WAS SCHEDULED FOR (B)(6) 2024. ADDITIONAL INFORMATION WAS SOLICITED.

Additional Manufacturer Narrative

THIS CASE IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR UPON COMPLETION OF THE INVESTIGATION BY THE MANUFACTURING PLANT.