HEMICAP® MTP RESURFACING HEMI-ARTHROPLASTY SYSTEM

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 12 SEPTEMBER 2024 ARTHROSURFACE RECEIVED AN UNSOLICITED INQUIRY REQUESTING INSTRUMENTATION TO PERFORM A REVISION PROCEDURE ON A 72-YEAR-OLD MALE PATIENT WHO WAS DIAGNOSED WITH TYPE 2 DIABETES MELLITUS. UPON FURTHER INQUIRY THE HCP REPORTED THAT THE PATIENT RECEIVED A TOE HEMICAP IMPLANT (DATE OF INITIAL IMPLANT IS UNKNOWN) AND THAT THE IMPLANT MALFUNCTIONED A FEW YEARS AGO (MALFUNCTION TYPE NOT REPORTED). THE PATIENT ALSO REPORTED EXPERIENCING PAIN. X-RAY IMAGE WAS PROVIDED, AND A CURSORY ENGINEERING ASSESSMENT IS THAT THERE IS NO INDICATION OF A FAILURE BASED ON THE X-RAY IMAGE. THE REVISION DATE IS UNKNOWN. THE HCP STATED THAT THE PATIENT'S TOE WILL BE FUSED AFTER THE DEVICE HAS BEEN EXPLANTED. PATIENT ACTIVITY IS NOT KNOWN. ADDITIONAL INFORMATION HAS BEEN SOLICITED.

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 BY THE MANUFACTURING PLANT.

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 (B)(6) 2024 ARTHROSURFACE RECEIVED AN UNSOLICITED INQUIRY REQUESTING INSTRUMENTATION TO PERFORM A REVISION PROCEDURE ON A 72-YEAR-OLD MALE PATIENT WHO WAS DIAGNOSED WITH TYPE 2 DIABETES MELLITUS. UPON FURTHER INQUIRY THE HCP REPORTED THAT THE PATIENT RECEIVED A TOE HEMICAP IMPLANT (DATE OF INITIAL IMPLANT IS UNKNOWN) AND THAT THE IMPLANT MALFUNCTIONED A FEW YEARS AGO (MALFUNCTION TYPE NOT REPORTED). THE PATIENT ALSO REPORTED EXPERIENCING PAIN. X-RAY IMAGE WAS PROVIDED, AND A CURSORY ENGINEERING ASSESSMENT IS THAT THERE IS NO INDICATION OF A FAILURE BASED ON THE X-RAY IMAGE. THE REVISION DATE IS UNKNOWN. THE HCP STATED THAT THE PATIENT'S TOE WILL BE FUSED AFTER THE DEVICE HAS BEEN EXPLANTED. PATIENT ACTIVITY IS NOT KNOWN. ADDITIONAL INFORMATION HAS BEEN SOLICITED.

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 BY THE MANUFACTURING PLANT. SUPPLEMENTAL REPORT: THE REPORTED EVENT IS NOT CONFIRMED. A HCP REQUESTED ASSISTANCE WITH INSTRUMENTS TO PERFORM A TOE HEMICAP IMPLANT REVISION PROCEDURE ON A TOE IMPLANT WHICH WAS REPORTEDLY IMPLANTED SOME TIME IN 2024. IT WAS REPORTED THAT THE IMPLANT FAILED. PATIENT COMORBIDITIES IS DM II (TYPE 2 DIABETES MELLITUS?) THE 72 YEAR OLD MALE PATIENT REPORTED EXPERIENCING PAIN DUE TO AN ALLEGED FAILURE OF THE TOE IMPLANT. AN X-RAY WAS PROVIDED AND REVIEWED BY ENGINEERING WHO REPORTED THAT THERE IS NO DEFECT APPARENT IN THE IMAGE. THE PATIENT TOE WILL BE FUSED. THE DATE OF THE REVISION IS UNKNOWN. ADDITIONAL INFORMATION WAS NOT PROVIDED UPON REQUEST. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE A REVIEW OF THE BATCH RECORD COULD NOT BE PERFORMED. A THREE YEAR RESTROSPECTIVE REVIEW OF ALL NONCONFORMANCES WAS PERFORMED. THERE ARE NO NONCONFORMANCES RELATED TO THE REPORTED EVENT. BASED ON THE LIMITED INFORMATION, THE CAUSE OF THE REPORTED EVENT COULD NOT BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW AND RELEVANT INFORMATION. THIS CASE WILL BE MONITORED AND TRENDED FOR FUTURE ANALYSIS.