P.F.C. SIGMA 96-2114Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295241133), received between Nov 20, 2017 and Dec 8, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANTS REMOVED DUE TO INSTABILITY AND ANTERIOR KNEE PAIN. SURGEON BELIEVES THE JOINT LINE WAS RAISED TOO MUCH RESULTING IN PATELLA BAJA. THERE WAS NO SURGICAL DELAY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 15939126 ↗
• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE PRIMARY SURGERY WITH THE COMPETITOR'S IMPLANTS. AFTER THE SURGERY, THE PATIENT UNDERWENT THE REVISION SURGERY WITH THE FEMORAL COMPONENT IN QUESTION AND THE INSERT IN QUESTION ON (B)(6) 2018, FOR UNKNOWN REASON. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE REVISION SURGERY, THE IMPLANTS HAD AN INSTABILITY ON AN UNKNOWN DATE. THEN, THE PATIENT UNDERWENT THE 3RD SURGERY WITH THE TC3 AND TC3 INSERT ON (B)(6) 2022. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2018, DOR: (B)(6) 2022, UNKNOWN SIDE.

  Patient problems: Joint Laxity

  MAUDE report 15804166 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 15313156 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF A SIGMA TC3 REVISION KNEE PROSTHESIS FOR INFECTION.

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

  MAUDE report 11091430 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FLEXION INSTABILITY WITH HER PREVIOUS KNEE REPLACEMENT. SURGEON TIGHTENED HER FLEXION GAP WITH A TC3 FEMUR, +2 BOLT AND TC3 RP INSERT. DOI: (B)(6) 2015 DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10461213 ↗
• InjuryNov 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL KNEE AND A SOFT TISSUE ISSUE WITH THE PATIENT'S MEDIAL COLLATERAL LIGAMENT BEING LOOSE. THE SURGEON PUT IN A TC3 INSERT.

  Patient problems: Pain

  MAUDE report 7045013 ↗