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P.F.C. SIGMA 95-1026Recalls & reported problems

Depuy (Ireland) · P.F.C. SIGMA TIBIAL INSERT ROTATING PLATFORM RP-F SIZE 2.5 12.5mm GVF · Class 3 · Implant

All models of P.F.C. SIGMA (487)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295230342), received between Mar 15, 2023 and Mar 15, 2023 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Pain1
  • Swelling/ Edema1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; 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 WIT

    Patient problems: Pain; Swelling/ Edema

    MAUDE report 16550473 ↗

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Sources and updates

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