P.F.C. SIGMA 96-2161Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295241508), received between Jun 1, 2018 and May 14, 2025 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

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

  PATIENT WAS REVISED DUE TO PAIN. IMPLANTED APPROXIMATELY 2009. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22022035 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND UNDERWENT LINER EXCHANGE WASHOUT TO RULE OUT INFECTION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21746238 ↗
• InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO OSTEOLYSIS. DATE OF IMPLANT: (B)(6) 2011, DATE OF REVISION: (B)(6) 2023, (LEFT KNEE). TREATMENT: FEMORAL COMPONENT, TIBIAL AND INSERT WERE REVISED.

  Patient problems: Osteolysis

  MAUDE report 18292088 ↗
• InjuryDec 7, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  PATIENT WAS REVISED FOR POLY WEAR. AFTER EXPOSING THE KNEE THE POLY WAS FRACTURED ON THE MEDIAL SIDE AND HAD A LOT OF POSTERIOR MEDIAL WEAR. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.(B)(6). AFFECTED SIDE- RIGHT KNEE

  Patient problems: Insufficient Information

  MAUDE report 18284215 ↗
• InjuryApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE KNEE WAS INFECTED AND WASHOUT WAS PERFORMED. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16662846 ↗
• InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS UNSTABLE KNEE FROM POST TRAUMATIC INJURY AND AUTOMOBILE ACCIDENT. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2016, DOE: (B)(6) 2022, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13471628 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD TOTAL KNEE REVISION FOR TIGHT, UNSTABLE KNEE. CULTURES WERE TAKEN, & PROVED THAT THERE WAS NO INFECTION. REVISION SURGERY THEN TOOK PLACE WITH REPLACEMENT OF THE COMPONENTS. THERE IS NO EXACT DATE OF PREVIOUS SURGERY. NO ADVERSE EVENTS TOOK PLACE DURING SURGERY. THERE IS NO MORE INFORMATION TO GIVE OR OBTAIN DUE TO PATIENT PRIVACY.

  Patient problems: Joint Laxity; Loss of Range of Motion

  MAUDE report 11280560 ↗
• InjuryJan 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS SEVERE SYNOVITIS WITH NO ASSOCIATED INFECTION NOR IMPLANT LOOSENING. DOI: (B)(6) 2009; DOR: (B)(6) 2020; (LEFT KNEE).

  Patient problems: No Code Available

  MAUDE report 9633177 ↗
• InjuryJun 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  INFECTED KNEE JOINT. PATIENT CONSEQUENCE? :UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7628959 ↗
• InjuryJun 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. POLY SWAP DONE. DOI: UNKNOWN. DOR: (B)(6) 2018. LEFT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7560083 ↗