Description of Event or Problem · 0
PATIENT DEVELOPED POSTOP SEROMAS. AFTER REPEATED TREATMENTS DOCTOR DECIDED TO REMOVE IMPLANT (DOS (B)(6) 2019). CALLED FOR REPLACEMENT IMPLANT (B)(6) 2019. DOCTOR'S OFFICE PURCHASED 3 IMPLANTS 501 - 304B WITH LOT # 17-10-008 (S/O# (B)(4)). ONE IMPLANT WAS RETURN UNOPENED (ARM# 17-321-03) AFTER SURGERY WAS COMPLETED ((B)(6) 2017) 2 IMPLANTS 501-304B, LOT# 17-10-008 WERE IMPLANTED. ACCORDING TO THE TIMELINE PROVIDE BY THE DOCTOR THE PATIENT DEVELOPED A SEROMA (SWELLING) AROUND ONE OF THE IMPLANTS POSTOP. THE SEROMAS CONTINUED THROUGH THE REST 2017 AND CONTINUED UP TO JULY 2019 WHEN THE IMPLANT WAS REMOVED. THE IMPLANT WAS THROWN AWAY BEFORE WE WERE CONTACTED REGARDING THIS COMPLAINT. WE RECEIVE NOTIFICATION OF THE ISSUE ON 10/22/2019. A REPLACEMENT IMPLANT WAS ORDERED 12/2/2019 (S/O (B)(4) LOT # 19-06-032) AND REIMPLANTATION OCCURRED IN (B)(6) 2020. ON (B)(6) 2020 FOLLOWED UP WITH DR WHO STATED NO FURTHER ISSUES FOLLOWING REIMPLANTATION. NOTE: ONLY ONE IMPLANT WAS CAUSING AN ISSUE FOR THE PATIENT, THE OTHER IMPLANT REMAINED IN THE PATIENT SINCE ORIGINAL SURGERY AND CAUSED NO SEROMAS OR OTHER COMPLICATIONS. ACQUIRED THE FOLLOWING TIMELINE FROM DOCTOR. (B)(6) 2017, PT FOLLOW UP SHOWED SOME SWELLING. DR PRESCRIBED ANTIBIOTICS (B)(6) 2017, NOTHING NEW NOTED, CONTINUED ANTIBIOTICS; (B)(6) 2017, PREVIOUS ISSUES HAVE SETTLED DOWN, APPEARS TO BE RECOVERING; (B)(6) 2018 FOLLOW UP FOR CHRONIC INFLAMMATION. DR RECOMMENDED REMOVAL. PATIENT DECLINED, CONTINUED ANTIBIOTICS; (B)(6) 2018, PT FOLLOW UP DR RECOMMENDED REMOVAL, PATIENT DID NOT SCHEDULE (B)(6) 2019. PT FOLLOW UP DR RECOMMENDED REMOVAL, (B)(6) 2019, IMPLANT REMOVED; (B)(6) 2019, RECEIVED FIRST REPORT OF COMPLAINT. ON (B)(6) 2019 REPLACEMENT IMPLANT ORDERED. ON (B)(6) 2020 NO FURTHER ISSUES REPORTED BY PATIENT PER DR. DR WAS UNABLE TO PROVIDE REASON FOR CONTINUED ISSUES. DEVICE (LOT #17-10-008) WAS MANUFACTURED WITH USP CLASS 6 IMPLANTABLE SILICONE THAT HAS BEEN TESTED TO MEET ALL USP SPECIFICATION PER CERTIFICATE OF COMPLIANCE DATED 07/27/2017. DEVICE WAS MANUFACTURED ACCORDING TO MF629 AND PASSED ALL INSPECTION CRITERIA W/T 17-10-008 REPLACEMENT DEVICE (LOT # 19-06-032) WAS MANUFACTURED WITH USP CLASS 6 IMPLANTABLE SILICONE THAT HAS BEEN TESTED TO MEET ALL USP SPECIFICATION PER CERTIFICATE OF COMPLIANCE DATED 04/04/2019. REPLACEMENT DEVICE WAS MANUFACTURED ACCORDING TO MF629 AND PASSED ALL INSPECTION CRITERIA W/T 19-06-032. FDA SAFETY REPORT ID # (B)(4).