HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS

Additional Manufacturer Narrative

THIS CASE IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION OR UPON COMPLETION OF THE INVESTIGATION AT THE MANUFACTURING PLANT. SUPPLEMENTAL REPORT: THE REPORTED EVENT IS NOT CONFIRMED BASED ON THE INFORMATION PROVIDED. ADDITIONAL INFORMATION WAS NOT PROVIDED UPON REQUEST. A CUSTOMER REQUESTED TO BE CONTACTED BY A LOCAL REPRESENTATIVE FOR A PATELLOFEMORAL ARTHROPLASTY REMOVAL WITH UNICAR/HEMICAR INPLANTS. THE PATIENT OF UNKNOWN AGE AND DEMOGRAPHIC WAS BEING REVISED FROM A ARTHROSURFACE HEMICAP WITH A TOTAL KNEE SYSTEM. THE REVISION DATE IS UNKNOWN. THERE WAS NO ALLEGATION OF ANY NEGATIVE PATIENT IMPACT OR DEVICE MALFUNCTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. PATIENT COMORBIDITIES IS UNKNOWN. A REVIEW OF THE BATCH RECORD WAS PERFORMED. THERE WAS NO NONCONFORMANCES RELATED TO THE REPORTED EVENT. THE DEVICE WAS MANUFACTURED TO APPLICABLE PROCEDURES AND SPECIFICATIONS. A THREE YEAR RETROSPECTIVE REVIEW OF NONCONFORMANCES WAS PERFORMED FOR THE REPORTED DEVICES. THERE WAS NO NONCONFORMANCES RELATED TO THE REPORTED EVENT. THE PLAUSIBLE ROOT CAUSE OF THE REPORTED EVENT HAS BEEN ATTRIBUTED TO THE LIFE EXPECTANCY OF THE IMPLANTS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION. THIS CASE WILL BE MONITORED AND TRENDED FOR FUTURE ANALYSIS.

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 ARTHROSURFACE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ARTHROSURFACE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. ON 18 SEPT 2024 ARTHROSURFACE RECEIVED AN UNSOLICITED INQUIRY BY A HCP REQUESTING A REPRESENTATIVE CONTACT THE CLINIC REGARDING EXPLANTING A ARTHROSURFACE HEMICAP ARTHROPLASTY SYSTEM. THE HCP STATED THAT THE PATIENT'S (UNKNOWN AGE AND DEMOGRAPHIC) DISEASE (UNSPECIFIED) HAS PROGRESSED AND WILL BE REVISED WITH A TOTAL KNEE IMPLANT, (MANUFACTURER / TYPE UNKNOWN). THE HCP STATED THAT THERE WAS NO APPARENT DEFECT WITH THE ARTHROSURFACE IMPLANT. THE ORIGINAL IMPLANT DATE IS UNKNOWN. THE REVISION PROCEDURE DATE IS UNKNOWN. THE PART NUMBERS AND LOT NUMBERS OF THE INITIAL IMPLANT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN SOLICITED. THIS IS ONE OF THREE SUBMISSIONS FOR THE SAME EVENT.

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 ARTHROSURFACE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ARTHROSURFACE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. ON 18 SEPT 2024 ARTHROSURFACE RECEIVED AN UNSOLICITED INQUIRY BY A HCP REQUESTING A REPRESENTATIVE CONTACT THE CLINIC REGARDING EXPLANTING A ARTHROSURFACE HEMICAP ARTHROPLASTY SYSTEM. THE HCP STATED THAT THE PATIENT'S (UNKNOWN AGE AND DEMOGRAPHIC) DISEASE (UNSPECIFIED) HAS PROGRESSED AND WILL BE REVISED WITH A TOTAL KNEE IMPLANT, (MANUFACTURER / TYPE UNKNOWN). THE HCP STATED THAT THERE WAS NO APPARENT DEFECT WITH THE ARTHROSURFACE IMPLANT. THE ORIGINAL IMPLANT DATE IS UNKNOWN. THE REVISION PROCEDURE DATE IS UNKNOWN. THE PART NUMBERS AND LOT NUMBERS OF THE INITIAL IMPLANT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN SOLICITED. THIS IS ONE OF THREE SUBMISSIONS FOR THE SAME EVENT.

Additional Manufacturer Narrative

THIS CASE IS STILL UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION OR UPON COMPLETION OF THE INVESTIGATION AT THE MANUFACTURING PLANT.