P.F.C. SIGMA 1581-14-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295063513), received between Mar 24, 2018 and Jan 14, 2025 — classified as 18 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 21149140 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO 20 DEGREE FLEXION CONTRACTURE. SURGEON PERFORMED SOFT TISSUE RELEASES AND DEBRIDEMENT AND DID POLY SWAP TO PLI INSERT AND DOWNSIZE TO AN 8 MM THICKNESS FROM A 10 MM. SURGICAL DELAY UNKNOWN. ACTIVITY LEVEL - YES. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Contracture

  MAUDE report 19731629 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD POLY EXCHANGE DUE TO INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18920438 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LEFT KNEE REPLACEMENT. IN THE FOLLOWING WEEKS THE PATIENT DEVELOPED A FEVER AND KNEE BECAME INFECTED. THE SURGEON DECIDED TO DO AN IRRIGATION AND DEBRIMENT WITH A POLY EXCHANGE. SURGERY WAS DONE WITH INCIDENT. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 17039976 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AND NEEDED A LINER EXCHANGE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16466354 ↗
• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO VERY STIFF KNEE. SYNOVECTOMY AND FEMORAL REVISION WERE PERFORMED. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 15752438 ↗
• InjuryOct 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PT HAS PAINFUL AND INFECTED RIGHT KNEE IMPLANTED 8 YEARS AGO. PRIMARY SURGEON UNKNOWN. DR. WILSON REMOVED PFC SIGMA FEMUR, POLY, TIBIAL BASEPLATE, AND PATELLA COMPONENTS FOR FIRST STAGE REVISION. DOI: 8 YEARS AGO, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 12680941 ↗
• InjuryAug 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT KNEE WAS REVISED DUE TO INSTABILITY. THE PATIENT'S PRIMARY 10MM SIGMA CURVED INSERT WAS REPLACED BY A THICKER 12.5MM SIGMA CURVED PLUS INSERT. DOI: (B)(6) 2018; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12285723 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INSTABILITY WAS DUE TO AN ACCIDENT AND PCL WAS COMPROMISED.

  Patient problems: Joint Laxity

  MAUDE report 11793788 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. UPSIZED INSERT FROM A 10 MM CURVED TO A 12.5 CURVED PLUS. DOI: UNKNOWN DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11411862 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. REPLACED CURVED POLY WITH A CURVED PLUS FOR ADDED STABILITY. NO LOOSENING AND NO DELAY TO SURGERY REPORTED. DOI: (B)(6) 2013, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11407193 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFFECTED SIDE: RIGHT KNEE.

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

  MAUDE report 11405274 ↗
• InjuryFeb 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PT REQUIRED REVISION TOTAL KNEE REPLACEMENT PATELLA RESURFACING AND LINER EXCHANGE, FOR PATELLA-FEMORAL SYMPTOMS. WHEN INSERTING THE NEW POLYETHYLENE LINER THE TIBIAL IMPACTOR HEAD BROKE INTO TWO PIECES AFTER BEING STRUCK WITH THE MALLET. WHEN THE SURGEON INSPECTED THE INSERT IT WAS DAMAGED. A NEW POLYETHYLENE INSERT WAS USED AND A NEW TIBIAL IMPACTOR HEAD WAS USED TO DO THIS. THE REASON FOR LINER EXCHANGE AND PATELLA RESURFACING WAS PATELLO-FEMORAL SYMPTOMS AND PAIN AS PER THE SURGEON PERFORMING THE REVISION. AN INFECTION WAS SUSPECTED HOWEVER URGENT SAMPLES SENT REVEALED NO INFECTION WAS PRESENT. LEFT SIDE.

  Patient problems: Pain

  MAUDE report 11367002 ↗
• InjuryJan 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON PERFORMED POLY EXCHANGE ON SIGMA TOTAL KNEE REPLACEMENT DUE TO INFECTION. SIZE 4 CURVED POLY WAS REMOVED AND NEW POLY INSERTED. PATIENT DEMOGRAPHICS: (B)(6) YEAR OLD CAUCASIAN MALE. FURTHER DEMOGRAPHICS UNKNOWN. SURGEON STATED PREVIOUS SURGEON AND HOSPITAL OPERATION DETAILS UNAVAILABLE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES: UNKNOWN, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(6). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

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

  MAUDE report 11185514 ↗
• InjuryFeb 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN OVER TIBIA. DOI: (B)(6) 2015; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9693571 ↗
• InjurySep 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION TO ADDRESS WOUND DEHISCENCE AND INFECTION. TREATMENT INCLUDES IRRIGATION AND DEBRIDEMENT. DOI: (B)(6) 2018, DOR: (B)(6) 2018, (RIGHT KNEE).

  Patient problems: Not Applicable; Unspecified Infection; Wound Dehiscence

  MAUDE report 7918003 ↗
• InjuryMay 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT HAS A REMOTE POSSIBILITY OF BEING DEVICE RELATED AND IS PROBABLY PROCEDURE RELATED. DOI: (B)(6) 2010, DOE: (B)(6) 2010, DOR: (B)(6) 2018, (LEFT KNEE).

  Patient problems: Joint Disorder; No Code Available; Not Applicable

  MAUDE report 7502014 ↗
• InjuryMar 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN. COULD ONLY GET APPROX 20 DEGREES OF FLEXION PREOP. APPEARED TO BE BONE OVERGROWTH POSTERIORLY TO FEMUR WHICH A GOOD PORTION WAS REMOVED DURING SURGERY. ALSO A FEW RELEASES WERE MADE TO INCREASE RANGE BUT DECISION WAS MADE TO RESURFACE TIBIA AND CEMENT IN A SZ 4 TRAY WITH A 15 X 30 STEM. SHE REGAINED 90 DEGREES OF FLEXION. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 7368524 ↗