P.F.C. SIGMA 1581-23-112Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295064343), received between Nov 2, 2017 and Apr 10, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR JOINT CREPITUS WITHOUT INSTABILITY. THEY WERE RETURNED FOR A POLY SWAP. THE IMPLANTS WERE WELL FIXED. DOI: (B)(6) 2012. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT.

  Patient problems: Crepitus

  MAUDE report 24844812 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION, POLY SWAP. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22508408 ↗
• InjuryMar 28, 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 KNEE INSTABILITY. IT WAS UNKNOWN IF THERE WAS ANY LOOSENING. DOI: (B)(6) 2011 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19000047 ↗
• InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND STIFFNESS. LEFT KNEE DOWNSIZED THE POLY FROM 12.5 TO 10 MM. POLY EXCHANGE WAS PERFORMED. DOI: UNKNOWN. DOR: (B)(6) 2023 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 18066730 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION SO THE SURGEON WASHED OUT AND REPLACED THE POLY INSERT. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18011575 ↗
• InjuryJul 27, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT CAME IN FOR INSTABILITY. POLY WAS WORN, TRIALED THE SAME SIZE AND REIMPLANTED A 12.5. DOI: (B)(6) 1999. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17404950 ↗
• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. RESECTION & INSERTION OF ANTIBIOTIC SPACE MOLD. NO ADDITIONAL INFORMATION & POLY EXCHANGE (B)(6) 2019. DOI: UNKNOWN (PATELLA, TIBIA AND FEMUR), (B)(6) 2019 (TIBIAL INSERT), DOR: (B)(6) 2021. UNKNOWN KNEE SIDE.

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

  MAUDE report 12203526 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. SURGEON DID A WASH OUT AND POLY EXCHANGE. NO AVAILABLE LOT NUMBER ON THE POLY THAT WAS ORIGINALLY INSERTED/EXPLANTED NOR HAVE THE DATE OF THE ORIGINAL SURGERY. EXPLANTED 3X12.5 INSERTED A NEW 3X12.5. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9940273 ↗
• InjuryJan 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INSTABILITY. POLY EXCHANGE WAS DONE. NO ADDITIONAL INFORMATION. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9628735 ↗
• InjuryJan 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9606850 ↗
• InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION, IRRIGATION AND DEBRIDEMENT WAS PREFORMED WITH AN EXCHANGE OF THE POLYETHYLENE INSERT. DOI: (B)(6) 2019; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8807031 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAINFUL STIFF KNEE. DOI: (B)(6) 2018, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8757665 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I&D OF KNEE, POLY EXCHANGE WERE PERFORMED. DOI: (B)(6) 2009; DOR: (B)(6) 2019 UNKNOWN SIDE.

  Patient problems: Discomfort; No Code Available

  MAUDE report 8600834 ↗
• InjuryApr 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE SURGEON SAID PATIENT WAS IN PAIN AND WANTED TO REVISE. THOUGHT FEMUR WAS OVERSIZED AND LOOSE TIBIA. TIBIA WAS DIFFICULT TO REMOVE. OLDER SIGMA KNEE. DOI: UNKNOWN. DOR: (B)(6) 2018, LEFT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7454356 ↗
• InjuryNov 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7005646 ↗
• InjuryNov 2, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6998295 ↗