P.F.C. SIGMA RPFRecalls & reported problems across all models

We found 12 models of P.F.C. SIGMA RPF by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between Jul 13, 2017 and Sep 30, 2026 — classified as 39 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (20 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported P.F.C. SIGMA RPF problems

P.F.C. SIGMA RPF models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• P.F.C. SIGMA RPF 95-0013

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  5 reports
• P.F.C. SIGMA RPF 95-0014

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  5 reports
• P.F.C. SIGMA RPF 95-0022

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  5 reports
• P.F.C. SIGMA RPF 95-0023

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  5 reports
• P.F.C. SIGMA RPF 95-0012

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  3 reports
• P.F.C. SIGMA RPF 95-0015

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  3 reports
• P.F.C. SIGMA RPF 95-0016

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  3 reports
• P.F.C. SIGMA RPF 95-0024

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  3 reports
• P.F.C. SIGMA RPF 95-0026

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  3 reports
• P.F.C. SIGMA RPF 95-0025

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  2 reports
• P.F.C. SIGMA RPF 95-0010

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  1 report
• P.F.C. SIGMA RPF 95-0027

  Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
  1 report

Recent P.F.C. SIGMA RPF adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2010, the patient underwent a TKA with the product in question. The surgery was completed successfully without any delay.After the surgery on (b)(6) 2026, the hospital ordered replacement for a debridement and insert replacement following an infection. Upon checking with the logistics department, it was found that there was virtually no stock of RPF inserts remaining; as replacement with a new unit was not possible, the surgeon decided to thoroughly clean and reuse the existing insert. The surgery was completed successfully without any delay.Affected Side: Left.

  Patient problems: Unspecified Infection

  MAUDE report 50945009 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. Darthmouth is the research location, and not the facility of placement. A DePuy Synthes Implant was revised and reviewed for analysis.Reason for revision: Revision due to pain and stiffness.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 50179895 ↗
• InjuryFeb 5, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT PRIMARY TOTAL KNEE ARTHROPLASTY (TKA) ON LEFT KNEE WITH THE PRODUCT IN QUESTION. POSTOPERATIVELY, LOOSENING WAS IDENTIFIED IN THE FEMORAL AND TIBIAL COMPONENTS, LEADING TO A REVISION TKA ON (B)(6) 2026. THE FEMORAL COMPONENT DETACHED EASILY UPON REMOVAL OF THE INSERT, AND SIGNIFICANT LOOSENING WAS ALSO OBSERVED IN THE TIBIAL TRAY, BOTH OF WHICH WERE REMOVED WITHOUT DIFFICULTY. THE REVISION WAS PERFORMED DUE TO FINDINGS OF LOOSENING AND SEVERE PAIN WITH EDEMA. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ALTERNATIVE PRODUCTS, AND THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 24273908 ↗
• InjuryFeb 5, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT A PFC SIG RPF CEM FEM SZ 3 LT, UNKNOWN KNEE TIBIAL TRAY, UNKNOWN KNEE TIBIAL INSERT, AND UNKNOWN KNEE PATELLA WERE INVOLVED IN A REPORTED EVENT. THE EVENT CONCERNED REVISION SURGERY OF A KNEE CONSTRUCT, INCLUDING A FEMORAL COMPONENT, TIBIAL TRAY, TIBIAL INSERT, AND PATELLA. THE REVISION WAS NECESSITATED BY LOOSENING ATTRIBUTED TO POLY LYSIS, WITH MEDIAL WEAR OBSERVED ON THE INSERT. BOTH THE FEMUR AND TIBIA WERE FOUND TO BE LOOSE, WHILE THE PATELLA WAS REVISED DUE TO POLYETHYLENE WEAR. ALL COMPONENTS WERE EXPLANTED. THE PATIENT REQUIRED A CORRECTIVE INVASIVE PROCEDURE IN WHICH THE DEVICES WERE REPLACED OR REVISED. THE LOOSENING WAS IDENTIFIED AT THE IMPLANT TO CEMENT INTERFACE, AND WEAR OR DETERIORATION OF POLYETHYLENE MATERIAL WAS NOTED. OSTEOLYSIS WAS ALSO REFERENCED AS A RELATED CONDITION. IMPLANTED IN 2006. EXPLANTED (B)(6) 2026.

  Patient problems: Insufficient Information

  MAUDE report 24267145 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2006. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19042918 ↗
• InjuryFeb 27, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED: NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 18788769 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUSPECTED PERIPROSTHETIC INFECTION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 18248185 ↗
• InjuryNov 21, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2019, THE PRIMARY SURGERY WAS PERFORMED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER SURGERY, ON AN UNKNOWN DATE, INFECTION WAS CONFIRMED. DETAILS SUCH AS THE CAUSE OF THE INFECTION AND PLANS FOR REOPERATION ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION RECEIVED: THERE WAS NO INFECTION. IT TURNED OUT TO BE FEMORAL DE-BONDING, SO THE IMPLANT WAS REMOVED ON (B)(6), 2023 AND REVISION SURGERY IS SCHEDULED FOR (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18180903 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. IT WAS UNKNOWN IF THERE WAS ANY LOOSENING OF FEMUR OR TIBIA AT CEMENT TO IMPLANT INTERFACE. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2007. DOR: (B)(6) 2023.AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16930165 ↗
• InjuryMay 9, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2012, THE PRIMARY SURGERY WAS PERFORMED VIA TKA WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON AN UNKNOWN DAY IN (B)(6) 2023, THE PATIENT VISITED THE DOCTOR COMPLAINING OF PAIN. NO LOOSENING WAS OBSERVED IN THE X-RAY FINDINGS. ON (B)(6) 2023, LOOSENING OF THE IMPLANTS DUE TO DEBONDING WAS CONFIRMED BY OPEN WOUND. THE IMPLANTS WERE REVISED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 16894577 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. IMPLANTING ATTUNE REVISION. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16859774 ↗
• InjuryApr 24, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2008, THE PRIMARY SURGERY WAS PERFORMED VIA TKA FOR OA WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. IN 2023, LOOSENING WAS CONFIRMED. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, FOR IMPLANTS REPLACEMENT. THE CAUSE OF THE LOOSENING IS DEBONDING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16794967 ↗
• InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE AFFECTED PART WAS ON THE RIGHT SIDE.

  Patient problems: Joint Laxity

  MAUDE report 16592316 ↗
• 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 ↗

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