P.F.C. SIGMA 1581-23-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10603295064336), received between Jul 21, 2017 and Jul 2, 2025 — classified as 23 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. WASHOUT POLY EXCHANGE WITH ANTIBIOTIC BEADS. DOI: 2009. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22384742 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO SUSPECTED INFECTION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21873024 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. PLEASE PROVIDE THE REASON FOR WASH OUT AND REVISION? THE REASON FOR WASH OUT AND REVISION IS FOR INFECTION. B. PLEASE PROVIDE THE DOI AND AFFECTED SIDE? DOI IS UNKNOWN AND AFFECTED SIDE IS RIGHT. C. WAS THERE ANY SURGICAL DELAY RELATED TO EVENT? NO.

  Patient problems: Unspecified Infection

  MAUDE report 21619962 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH POLY SWAP. DOI: (B)(6) 2020. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20311558 ↗
• MalfunctionJul 9, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE INSERT DOES NOT FIT PROPERLY. LOCKING ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19699956 ↗
• MalfunctionMay 11, 2023Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  ON (B)(6), A NEW CASE OF AN IMPLANT WITH A SECOND OPEN PACKAGE WAS REPORTED. THE IMPLANT IS PROPERLY HEAT SEALED, BUT WHEN OPENING THE SECOND INTERNAL CONTAINER WAS MANIPULATED AND OPENED, SO THE SURGEON DECIDED NOT TO USE IT, SINCE IT DID NOT GUARANTEE THE STERILITY OF THE IMPLANT, THUS HARMING THE PATIENT WHO REQUIRED SUCH MEASURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16909994 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. DOI- UNKNOWN; DOR- (B)(6) 2022; AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15965988 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AND MALALIGNMENT OF THE RIGHT KNEE. THERE WAS NO SURGICAL DELAY. DOI- (B)(6) 2020; DOR- (B)(6) 2022; AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15165030 ↗
• InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15027367 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND THE LINER WAS EXCHANGED. THERE WAS NO LOOSENING AND SURGICAL DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 14373013 ↗
• InjuryMar 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD POLY REVISION DUE TO LIGAMENT LAXITY AND INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13732260 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. NO SURGICAL DELAY. DOI: (B)(6) 2018, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 13258929 ↗
• InjuryNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. POLY SWAP WAS DONE AND NO FURTHER INFORMATION IS AVAILABLE. DOI: 2003, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12771747 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SHOWING SIGNS OF INFECTION AFTER 6+ YEARS. THE ORIGINAL SURGERY DATE IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2021 UNKNOWN AFFECTED SIDE.

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

  MAUDE report 11844929 ↗
• MalfunctionMay 3, 2021Expiration Date Error; Expiration Date Error

  IT WAS REPORTED BY PHYSICIAN THAT THERE WAS A SURGERY WHERE THERE WAS AN IMPLANT USED THAT WAS EXPIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11760693 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL ON HER KNEE AND OPENED THE INCISION UP. AN I&D WAS PERFORMED AND THE 3X10MM SIGMA PS FIXED BEARING POLY WAS EXCHANGED FOR A NEW ONE. DOI: (B)(6) 2020; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Fall; No Code Available; Wound Dehiscence

  MAUDE report 10755633 ↗
• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SEPTIC TOTAL KNEE, EXPLANTED DUE TO INFECTION DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT SIDE KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9491861 ↗
• InjuryDec 3, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF KNEE PAIN. SURGEON REVISED PATIENT'S PATELLA WITH A SIMPLE RECUT OF THE BONY SURFACE. HE REPLACED IT WITH A NEW PATELLA. HE REPLACED PATIENT'S POLY WHILE HE WAS THERE. IT WAS ALSO REPORTED THAT THERE WAS SLIGHT ARTICULAR SURFACE WEAR, SAME ON THE PATELLA. DOI: (B)(6) 2013; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9404959 ↗
• InjurySep 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. POLY WAS EXCHANGED. IT WAS ALSO REPORTED THAT THE 3-15MM TRIAL INSERT BROKEN WHEN REMOVING. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9039120 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8535977 ↗
• InjuryNov 15, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS PAIN, SWELLING AND POSSIBLE INFECTION.

  Patient problems: Pain; Swelling; Unspecified Infection; Wound Dehiscence

  MAUDE report 8075067 ↗
• InjuryDec 12, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE SURGEON SAID THAT THE PATIENT HAD A FALL AND DEVELOPED TISSUE NECROSIS ON HER KNEE. DOI: UNKNOWN ; DOR: (B)(6) 2017 ; UNKNOWN AFFECTED SIDE.

  Patient problems: Necrosis

  MAUDE report 7107988 ↗
• InjuryDec 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7074403 ↗
• InjuryOct 25, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT PATIENT BECAME ILL ROUGHLY 2 MONTHS POST OP AND WAS HOSPITALIZED. IT WAS BELIEVED THAT HER KNEE WAS SEEDED FROM THE ILLNESS. A ONE STAGE REVISION WAS PERFORMED FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6978763 ↗
• InjurySep 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT PATIENT PRESENTED FOR INFECTION AND WAS TREATED WITH ANTIBIOTICS. BROUGHT TO OPERATING ROOM AND POLY WAS REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 6847894 ↗