P.F.C. SIGMA 95-1020Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295230298), received between Sep 19, 2017 and Aug 7, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (3 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, 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  (b)(6) first report of retrievals for Statement of Work 10 for Q2 of 2026. (b)(6) 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 50180012 ↗
• 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 18248183 ↗
• InjuryAug 24, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT ON (B)(6) 2006, THE PRIMARY SURGERY WAS PERFORMED VIA TKA WITH THE INSERT IN QUESTION. THE PATIENT VISITED THE HOSPITAL ON AN UNKNOWN DATE ON (B)(6) 2023, AND THE SPIN-OUT OR BREAKAGE OF THE INSERT WAS CONSIDERED, AND POSSIBLE LOOSENING OF THE IMPLANT WAS SUSPECTED. ON (B)(6) 2023, THE REVISION SURGERY WAS PERFORMED. AFTER DEPLOYMENT, THE DAMAGE TO THE INSERT WAS EVIDENT AT THE SPINE AND MEDIAL REAR, AND MANY DEBRIS WERE FOUND TO HAVE DELAMINATED. THE SURGEON PERFORMED A SOFT-TISSUE SCRAPING, THOROUGHLY CLEANED THE AFFECTED AREA, INSERTED THE TRIAL, AND REPLACED THE INSERT WITH ONE OF THE SAME SIZE. THE OUTSIDE OF THE PATERA WAS ALSO WORN, BUT THE SURGEON DETERMINED THAT THE PATIENT WAS TOO OLD TO REPLACE IT. DOI: (B)(6) 2006. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17610845 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON IS ORDERING A PATIENT SPECIFIC SIGMA RPF KNEE-INLAY FOR A PLANNED REVISION BECAUSE OF INSTABILITY LEFT SIDE. DOI: (B)(6) 2011. DOR: PLANNED AS SOON AS PATIENT SPECIFIC IMPLANT WILL BE MANUFACTURED BY DEPUY - IF POSSIBLE (B)(6) 2023. THERE HAS BEEN NO ALLEGATION OF ANY PRODUCT DEFICIENCY.

  Patient problems: Joint Laxity

  MAUDE report 15950134 ↗
• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT KNEE, TIBIAL POLY FAILURE.

  Patient problems: No Code Available; Pain

  MAUDE report 10233654 ↗
• InjuryMar 18, 2020Fracture; Fracture

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2010 VIA TKA. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE TIBIAL INSERT (P/N: 951020) WITH AN UNKNOWN NEW TIBIAL INSERT BECAUSE THE PATIENT HAD UNSTEADINESS OF KNEE. THE EXPLANTED TIBIAL INSERT HAD SEVERELY BROKEN AT POSTERIOR SITE AND ITS POST. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 9848758 ↗
• InjurySep 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PAINFUL POST-OP. THIS CASE IS FROM HEALTH AUTHORITY. IT WAS REPORTED THAT THE PATIENT UNDERWENT BILATERAL KNEE ARTHROPLASTY IN ORDER TO RESTORE JOINT FUNCTION DUE TO OSTEOARTHRITIS OF BOTH KNEES 5 YEARS AGO. JOHNSON & JOHNSON PFC SIGMA RPF TOTAL KNEE SYSTEM WAS USED IN THE SURGERY ON (B)(6) 2014. THE PATIENT'S LEFT KNEE RECOVERED WELL AFTER SURGERY, AND THE RIGHT KNEE FUNCTION RECOVERED UNSATISFACTORILY WITH INSTABILITY AND FELT JOINT PAINFUL DURING WALKING. SHE WAS DIAGNOSED WITH INSTABILITY AFTER RIGHT KNEE ARTHROPLASTY ON (B)(6) 2019 AND UNDERWENT A RIGHT KNEE REVISION PROCEDURE ON (B)(6) 2019. INTRAOPERATIVE OBSERVATIONS WERE CONSISTENT WITH A DIAGNOSIS OF INSTABILITY, AND IT WAS NOT RELATED TO JOINT IMPLANT, IT IS RELATED TO SURGERY OR PATIENT. THE PATIENT'S JOINT FUNCTION RECOVERED AFTER REVISION SURGERY.

  Patient problems: No Code Available; Pain

  MAUDE report 9000711 ↗
• InjurySep 19, 2017Fracture; Fracture

  IT WAS REPORTED THAT DURING EXPLANTATION SURGEON NOTED CATASTROPHIC FAILURE OF POLYETHYLENE INSERT. ON (B)(6) 2017 UPON EVALUATION OF THE EXPLANT PHOTOGRAPHS, IMPLANT FRACTURE IS IDENTIFIED.

  Patient problems: No Information

  MAUDE report 6875406 ↗