P.F.C. SIGMA RPF 95-0013Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295224013), received between Aug 16, 2018 and Mar 15, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 15, 2023Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. THE PATIENT HAS A HISTORY OF EVENTS RELATING TO BOTH THE LEFT AND RIGHT KNEES. LEFT KNEE ON (B)(6) 2011: SUCCESSFUL LEFT TKA WAS COMPLETED WITH DEPUY SYNTHES IMPLANTS INCLUDING CEMENT X 2 AND PATELLA. ON (B)(6) 2017: XRAYS SHOW LEFT TKA IS "IN SOME VARUS". ON (B)(6) 2021 X-RAYS SHOW THE VALGUS ALIGNMENT OF THE LEFT KNEE. OSTEOLYSIS AND PROXIMAL MEDIAL CYST FORMATION ARE NOTED UNDER THE TIBIAL PROSTHESIS ON (B)(6) 2022: XRAYS NOTE "UNCHANGED LEFT TILT AND SETTLING" ON (B)(6) 2022: LEFT KNEE REVISION IS PERFORMED FOR PAIN AND SWELLING. THE TIBIAL TRAY HAD SETTLED SEVERAL MILLIMETERS PER X-RAY PRIOR. INTRAOPERATIVELY, THE FEMORAL COMPONENT HAD SOME "BUBBLES" AROUND THE EDGE WITH ROCKING THE PROSTHESIS. THE TIBIAL COMPONENT WAS NOTED TO BE GROSSLY LOOSE. THE FEMORAL COMPONENT ALSO HAD SIGNS OF LOOSENING. A NONDISPLACED FRACTURE OF THE LATERAL FEMORAL CONDYLE WAS NOTED WHICH WAS TREATED WITH A PLATE AND SCREWS PRIOR TO THE REPLACEMENT OF THE FEMORAL COMPONENT. ALL COMPONENTS WERE REVISED WITH EXCEPTION OF THE PATELLA. (THIS REVISION WILL BE UPDATED AND REMAIN CAPTURED ON THIS PC (B)(4). ON (B)(6) 2022: PATIENT HAS A LEFT DVT IN THE LEFT DFV THAT IS TREATED WITH

  Patient problems: Bone Fracture(s); Pain; Swelling/ Edema

  MAUDE report 16550471 ↗
• InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE PRIMARY SURGERY WITH IMPLANTS IN QUESTION. ACCORDING TO THE PATIENT'S RECOLLECTION, THE SURGERY WAS ABOUT 20 YEARS AGO. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT PRESENTED WITH SYMPTOMS OF SUSPECTED LATE-ONSET INFECTION. THE EXTRACTION SURGERY WAS PERFORMED AND SUCCESSFULLY COMPLETED WITHOUT DELAY ON (B)(6) 2023. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 16407546 ↗
• InjuryFeb 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS POLYETHYLENE WEAR AND INSTABILITY. DATE OF IMPLANTATION: (B)(6) 2004, DATE OF REVISION: (B)(6) 2020, (LEFT KNEE). TREATMENT: FEMUR, TIBIAL TRAY, AND TIBIAL INSERT REVISED.

  Patient problems: Joint Laxity

  MAUDE report 11294748 ↗
• InjuryDec 13, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 8161569 ↗
• InjuryAug 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN, POSSIBLE INFECTION. CULTURES WAS OUT CLEAN AND SURGEON REVISED TO A TC3 KNEE REVISION. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7790821 ↗