P.F.C. SIGMA 1581-22-112Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295064183), received between Jul 21, 2017 and Sep 2, 2025 — classified as 15 injuries.

The most frequently reported specific device problem is “Fracture” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INSTABILITY. EXPLANTED THE 12.5MM INSERT. IMPLANTED A NEW SZ 2.5, 17.5 INSERT. THERE WAS NO LOOSENING. DEPUY CEMENT WAS USED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22939679 ↗
• InjuryMay 23, 2024Adverse 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 DISCOMFORT. THERE WAS NO LOOSENING. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN.

  Patient problems: Discomfort

  MAUDE report 19382733 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION, POLY SWAP WASH OUT WERE PERFORMED. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15120793 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORTS: IT WAS REPORTED THAT RESECTION WAS PERFORMED FOR INFECTION. DOI: (B)(6) 2017, DOR: UNKNOWN, RIGHT KNEE.

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

  MAUDE report 12437951 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS MID FLEXION INSTABILITY. SURGEON REMOVED 2.5X12.5 STABILIZED INSERT AND REPLACED WITH A 2.5X15 MM. THE PATIENT RETAINED THE PATELLA, FEMORAL COMPONENT AND TIBIAL TRAY. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11826650 ↗
• InjuryApr 5, 2021Adverse 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) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11613659 ↗
• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I & D LEFT KNEE INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2020.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10763505 ↗
• InjuryMar 2, 2020Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS STATED THAT THE SIGMA FB KNEE POLYETHYLENE WAS NOTED TO HAVE WEAR ON THE POSTERIOR-MEDIAL ASPECT WITH SOME CRACK AND YELLOWISH COLOR.

  Patient problems: No Code Available

  MAUDE report 9776258 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAINFUL LEFT KNEE DOI: (B)(6) 2014. DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9538659 ↗
• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Code Available; Pain

  MAUDE report 9411978 ↗
• InjurySep 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT RETURNED TO SURGERY FOR REVISION TO A KNEE SPACER FOR AN INFECTION. ALL THE IMPLANTS WERE REMOVED. DOI: (B)(6) 2018; DOR: (B)(6) 2019 RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9078412 ↗
• InjuryMar 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN, POSSIBLE SWELLING AND REDNESS. SURGEON PERFORMED AN I & D AND EXCHANGED THE POLY. DOI: (B)(6) 2017; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Pain; Swelling

  MAUDE report 8421092 ↗
• InjuryMar 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN AND INSTABILITY. DOI: (B)(6) 2016; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8421055 ↗
• InjuryMay 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENTS UNDERGOING TOTAL KNEE ARTHROPLASTY SURGERY, POSTOPERATIVE SECONDARY TO PAIN. SURGERY-RELATED, MEDICATION AND PHYSICAL THERAPY, IMPROVED. DOI: UNKNOWN DOR: (B)(6) 2018 UNKNOWN AFFECTED SIDE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7514058 ↗
• InjuryJul 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATED THAT THE PATIENT HAD A LEFT TRK IN 2014 (A SIGMA PS FB). PATIENT KNEE WAS TAPPED DUE TO PAIN. PATIENT BROUGHT TO OR FRIDAY (B)(6). LEFT KNEE OPENED AND POLY REMOVED. I&D PERFORMED. NEW POLY IMPLANTED, LEFT KNEE CLOSED.

  Patient problems: Pain

  MAUDE report 6732066 ↗