P.F.C. SIGMA 1581-13-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295063391), received between Sep 27, 2017 and Aug 7, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Appropriate Device Problem Term/Code Not Available

  Thayer School of Engineering at Dartmouth first report of retrievals for Statement of Work 10 for Q2 of 2026. Dartmouth 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 instability. The non-articular surface of the fixed-bearing polyethylene tibial insert shows moderate yellowing.

  Patient problems: Joint Laxity

  MAUDE report 50174300 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. STATES, THAT THE AFFECTED SIDE WAS THE RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19447888 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AS SHE WAS FEELING UNSTABLE AND THE POLY WAS REMOVED. THE SURGEON REPLACED IT WITH A THICKER POLY. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17958023 ↗
• InjuryJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REMOVAL OF THE POLY WAS DONE DUE TO FEELING UNSTABLE. REPLACED WITH A CURVED PLUS POLY TO ADD STABILITY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14772934 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS SLIGHT INSTABILITY. POLY SWAP WAS PERFORMED; WENT FROM A 10 CURVED TO A 10 CURVED PLUS. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14684850 ↗
• MalfunctionJul 22, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE INSERT DID NOT SEAT FULLY INTO THE TIBIAL TRAY. THE DOCTOR EXCHANGED FOR A NEW INSERT AND IT SEATED FULLY. THE DOCTOR FELT THAT THE SOFT TISSUE PROBABLY HELD THE INSERT FROM SEATING FULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211111 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2008, THE PATIENT HAD A LEFT CEMENTED TOTAL KNEE ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS, END-STAGE. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA WERE USED DURING THIS PROCEDURE. THERE WERE NO COMPLICATIONS NOTED. ON (B)(6) 2010, THE PATIENT HAD A REVISION, IRRIGATION AND DEBRIDEMENT LEFT PROXIMAL TIBIAL ABSCESS DUE TO PROXIMAL TIBIAL SOFT TISSUE ABSCESS AND PROBABLE CHRONIC INFECTION LEFT TOTAL KNEE ARTHROPLASTY. THE INDICATIONS FOR SURGERY NOTED THAT THE PATIENT HAD PAIN, INCREASED SWELLING, AND STIFFNESS. THE SURGEON REPORTED FINDING INFLAMMATION. NO COMPONENTS WERE REVISED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 11404589 ↗
• InjuryDec 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2010, THE PATIENT HAD A REVISION, IRRIGATION AND DEBRIDEMENT LEFT PROXIMAL TIBIAL ABSCESS DUE TO PROXIMAL TIBIAL SOFT TISSUE ABSCESS AND PROBABLE CHRONIC INFECTION LEFT TOTAL KNEE ARTHROPLASTY. THE INDICATIONS FOR SURGERY NOTED THAT THE PATIENT HAD PAIN, INCREASED SWELLING, AND STIFFNESS. THE SURGEON REPORTED FINDING INFLAMMATION. NO COMPONENTS WERE REVISED. ON (B)(6) 2018, THE PATIENT HAD AN INCISION AND DRAINAGE WITH DEBRIDEMENT PERIARTICULAR/EXTRACAPSULAR INFECTED CYST, LEFT KNEE ARTHROPLASTY DUE TO PERIARTICULAR INFECTED CYST, LEFT KNEE. THE INDICATIONS FOR SURGERY INCLUDED A HISTORY OF CHRONIC LEFT KNEE INFECTION. THE SURGEON REPORTED FINDING THE EXTRA ARTICULAR CYST TO BE INFECTED, WITH NO COMMUNICATION WITH THE KNEE JOINT.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inflammation; Muscular Rigidity; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 10942230 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS HEMATOMA. THE KNEE CAPSULE WAS OPENED UP AND THEN THOROUGHLY IRRIGATED AND DEBRIDED DURING THE REVISION PROCEDURE. THE PRIMARY KNEE TIBIAL INSERT WAS REPLACED BY A REPLACEMENT INSERT DURING THE SAME REVISION PROCEDURE. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available

  MAUDE report 10252223 ↗
• InjurySep 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN. DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8961511 ↗
• InjuryMar 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS SUBSEQUENT PAIN AND POOR ROM.

  Patient problems: Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8416144 ↗
• InjuryJul 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND STIFFNESS. DOI: (B)(6) 2015; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 7732093 ↗
• InjurySep 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL RIGHT KNEE FOLLOWING TKA. IT WAS ALSO DISCOVERED THAT THE PATIENT HAS A SEVERE NICKEL ALLERGY. SURGEON REMOVED INSERT, TIBIAL TRAY AND FEMUR. REPLACED WITH NICKEL FREE IMPLANTS.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 6896615 ↗