P.F.C. SIGMA 96-2154Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295241430), received between Feb 15, 2018 and Feb 25, 2025 — classified as 17 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTION IN BOTH KNEES. POLYS WERE SWAPPED FOR NEW ONES OF THE SAME SIZE. DOI: (B)(6) 2013. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21462366 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AS THERE WAS FEELING OF SOME INSTABILITY. A PATELLA AND POLY EXCHANGE WAS PERFORMED. NO DELAYS, NO BROKEN INSTRUMENTS. DOI:(B)(6) 2001. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19949262 ↗
• InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR CHRONIC EFFUSION, DECREASED ROM, AND INCREASED PAIN.. FEMORAL REVISION AND POLY EXCHANGE PERFORMED. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 17928192 ↗
• InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SUSPECTED INFECTION. I&D WAS DONE. NO WAY TO CONFIRM INFECTION. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15690830 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO UNKNOWN REASONS. PATIENT WAS REVISED TO A HINGE. NOTHING FURTHER TO REPORT. THE CEMENT MANUFACTURER WAS NOT INDICATED. NO LOOSENING EXPERIENCED. NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15336451 ↗
• InjuryJul 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE IS BEING LOGGED TO CAPTURE PATIENTS 1ST REVISION REPORTED IN (B)(4) - 3RD REVISION DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 12179988 ↗
• InjuryJul 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE IS TO CAPTURE PATIENTS¿ PRIOR REVISIONS REPORTED IN (B)(4). THIS WAS THE FOURTH REVISION FOR THIS PATIENT: PATIENT UNDERWENT A LEFT PRIMARY TOTAL KNEE REPLACEMENT (TKR) ON (B)(6) 2009. REVISED ON (B)(6) 2018 TO TREAT PAIN. ONLY THE INSERT WAS REVISED. PATIENT HAS A HISTORY OF REVISIONS DUE TO TIBIAL PAIN.

  Patient problems: Pain

  MAUDE report 12176727 ↗
• InjuryFeb 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11358442 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10895544 ↗
• InjuryNov 18, 2020Adverse 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 INSTABILITY. DATE OF IMPLANTATION: (B)(6) 2007, DATE OF REVISION: (B)(6) 2009, (LEFT KNEE). TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: No Code Available

  MAUDE report 10862680 ↗
• InjurySep 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTED KNEE. POLY WAS SWAPPED OUT IN THE PREP WAS OF WASHING OUT. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10554787 ↗
• InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION OF THE KNEE. NO INDICATION OF INSTABILITY OR FAULT OF PRODUCT BY DOCTOR OR STAFF. NO SURGICAL DELAY NOTED. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10197290 ↗
• InjuryFeb 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A DRAINING WOUND. I&D WITH POLY EXCHANGE WAS PERFORMED. NO COMPONENTS WERE LOOSE. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9694091 ↗
• InjuryMay 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO PAIN, STIFFNESS AND OSTEOLYTIC LESIONS. DOI: (B)(6) 2008; DOR: (B)(6) 2019; (RIGHT KNEE). INSERT REVISED AND LYTIC LESIONS REMOVED.

  Patient problems: No Code Available; Osteolysis; Pain

  MAUDE report 8608685 ↗
• InjuryNov 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY.

  Patient problems: No Code Available; Pain

  MAUDE report 8055318 ↗
• InjuryFeb 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS MEDIAL KNEE PAIN AND GRINDING FEELING DUE TO OSTEOPHYTES. KNEE WAS CLEANED UP OF OSTEOPHYTES AND ANY IMPINGEMENT. THICKER INSERT WAS USED TO PRODUCE A STABLE KNEE FREE OF GRINDING. DOI: UNKNOWN; DOR: (B)(6) 2018: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 7280087 ↗
• InjuryFeb 15, 2018Naturally Worn; Naturally Worn

  DER STATES PAIN AND DECREASED RANGE OF MOTION. PATIENT HAD TIBIA REVISED ON (B)(6) 2010. DATE OF ORIGINAL IMPLANTATION IS UNKNOWN. TODAY PATELLA SHOWED SIGNIFICANT WEAR AND POSTERIOR ASPECT OF INSERT WAS WORN. FEMUR REVISED TO TC3 WITH A STEM AND TC3 INSERT WAS PLACED, PATELLA WAS ALSO REVISED, TIBIA REMAINS INSITU. DOI: (B)(6) 2010; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 7273036 ↗