SILKTOE

Additional Manufacturer Narrative

THE REPORT WAS RECEIVED FROM AN ITALIAN HOSPITAL FACILITY, THROUGH THE ITALIAN DISTRIBUTOR. THE REPORT CONCERNED THE PERFORMANCE OF REVISION SURGERY IN PATIENT WITH MCP SILKTOE PROSTHESIS. FROM THE RADIOGRAPHIC DATA, THE PROSTHESIS APPEARED TO BE WELL IMPLANTED AND WITHOUT PROBLEMS, BUT THE PATIENT CONTINUED TO COMPLAIN OF PAIN, SO THE SURGEON ORDERED REVISION SURGERY. DURING THE EXPLANTATION, THE SURGEON NOTICED THE PRESENCE OF A FRACTURE IN THE SILICONE. UPON RECEIPT OF THE REPORT, THE MANUFACTURER PUT IN PLACE APPROPRIATE VERIFICATIONS. THE PRODUCTION REPORTS AND RAW MATERIAL CERTIFICATES FOR THE BATCH WERE FOUND TO BE IN COMPLIANCE WITH THE STANDARD. THE DEVICES BELONG TO A BATCH MANUFACTURED IN THE YEAR 2020 AND CONSISTING OF (B)(4), ALL OF WHICH WERE FOUND TO HAVE BEEN SOLD. NO OTHER REPORTS WERE RECEIVED ON THE SAME BATCH. THE FACILITY WAS CONTACTED AND PROVIDED THE RADIOGRAPHIC IMAGES OF THE PATIENT; IT ALSO RETURNED THE DEVICE. FROM THE RADIOGRAPHIC IMAGES, THE GROMMETS APPEAR POORLY ADHERED TO THE RELEVANT BONY PORTIONS, RESULTING IN THE PLANTAR PORTION BEING VERY CLOSE TOGETHER. THE RETURNED SPECIMEN WAS ALSO SUBJECTED TO STEREOSCOPIC ANALYSIS TO IDENTIFY FRACTURE POINTS. THE SPACER SHOWS DAMAGE AT SOME AREAS IN CONTACT WITH THE GROMMETS. THESE DAMAGES APPEAR TO BE CONSISTENT WITH THE GROMMET POSITIONING EVIDENCED BY THE RADIOGRAPHIC IMAGES. FINALLY, THE SURGEON WHO OPERATED ON THE PATIENT WAS CONTACTED. THE SURGEON REPORTED THAT THE PATIENT REFERRED PAIN IMMEDIATELY AFTER SURGERY, WITH REACTIVE TISSUE IN THE AFFECTED AREA. AT REVISION SURGERY, THE GROMMETS WERE WELL FIXED AND THE PROSTHESIS WELL POSITIONED, WITH NO SIGNS OF INFECTION OR OTHER PROBLEMS. HOWEVER, THE SURGEON DECIDED TO INSERT A NEW SILKTOE IMPLANT; THE PATIENT FROM IMMEDIATELY AFTER THE OPERATION WAS ABLE TO WALK WELL WITHOUT EXPERIENCING PAIN. POSSIBLE PAIN IN THE IMPLANT AREA AND IMPLANT RUPTURE ARE ALREADY LISTED IN THE IFU AS RESIDUAL RISKS OR EXPECTED SIDE EFFECTS. ADDITIONAL NOTE: THE MANUFACTURER WAS UNAWARE THAT INCIDENTS OCCURRING OUTSIDE THE UNITED STATES WERE ALSO CONSIDERED REPORTABLE BY FDA. THIS IS THE REASON WHY THE INCIDENT WAS REPORTED OUT OF THE REQUIRED TIMELINES.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY FOR A MTP1 SILICONE SILKTOE IMPLANT DUE TO PAIN SYMPTOMATOLOGY. AFTER EXPLANTATION, IT WAS NOTED THAT THE SILICONE DEVICE PRESENTED A SMALL FRACTURE AT THE BASE OF THE PHALANGEAL STEM. A SECOND MTP1 SILKTOE DEVICE WAS IMPLANTED AND THE PATIENT REPORTED NO RESIDUAL PAIN.