P.F.C. SIGMA 96-0860Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295234265), received between Feb 6, 2019 and Sep 23, 2024 — classified as 14 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC PAIN. PATIENT SEEN IN ED WITH DISLOCATED KNEE. CORRECTIVE SURGERY HAD MASSIVE METALLOSIS, OSTEOLYSIS, AND POLYETHYLENE WEAR. SURGICAL DELAY UNKNOWN. ACTIVITY LEVEL - YES. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 20280809 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC PAIN. PATIENT SEEN IN ED WITH DISLOCATED KNEE. CORRECTIVE SURGERY HAD MASSIVE METALOSIS, OSTEOLYSIS, AND POLYETHYLENE WEAR. SURGICAL DELAY UNKNOWN. ACTIVITY LEVEL: YES. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 20279448 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PER THE SURGEON, THE PATIENT WAS INFECTED. THE SURGEON REMOVED ALL COMPONENTS AND PUT IN SPACER. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2020. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18654999 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PER THE SURGEON, THE PATIENT WAS INFECTED. THE SURGEON REMOVED ALL COMPONENTS AND PUT IN SPACER. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2020. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18654979 ↗
• InjurySep 20, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS IDENTIFIED THAT ON (B)(6) 2023, THERE WAS A REPORT FOR ASEPTIC LOOSENING LEFT REVISION (KNEE HAS BEEN REVISED IN THE PAST) DOI: (B)(6) 2013. DOR: UNKNOWN. LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17781197 ↗
• InjuryMay 12, 2023Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT COMES FOR FURTHER DISCUSSION REGARDING PAINFUL BILATERAL TOTAL KNEE ARTHROPLASTIES. THE PATIENT HAD A RIGHT TOTAL KNEE IN 2006 AND REVISION IN 2019. SHE HAD A LEFT TOTAL KNEE IN 2006, A REVISION IN 2019 AND A SCOPE DEBRIDEMENT IN 2020. THE PATIENT CONTINUES TO HAVE ONGOING PAIN AND DISCOMFORT IN BOTH OF THE KNEES. THE PAIN IS DAILY. IT IS STARTING TO LIMIT HER ACTIVITIES. SHE HAS GOOD RANGE OF MOTION. SHE HAS SOME SWELLING AT TIMES. SHE HAS SOME GRINDING AND POPPING IN BOTH KNEES. THE LEFT KNEE HURTS MORE OFTEN THAN THE RIGHT KNEE. SHE DID PREVIOUSLY DISCUSS REVISION SURGERY WITH SURGEON. SHE WOULD LIKE TO PROCEED WITH STAGED TKA REVISIONS, LEFT ONE FIRST. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Discomfort; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 16918639 ↗
• InjuryMay 3, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL COMPONENT. ADAPTER BOLT WAS BROKEN AT THREADS. ALL PARTS WERE REMOVED. SLEEVE AND STEM WERE WELL FIXED AND WERE NOT REMOVED. S ROM HINGE FEMUR WAS IMPLANTED. TIBIAL COMPONENT WAS NOT REVISED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16860378 ↗
• InjuryMay 3, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL COMPONENT. ADAPTER BOLT WAS BROKEN AT THREADS. ALL PARTS WERE REMOVED. SLEEVE AND STEM WERE WELL FIXED AND WERE NOT REMOVED. S ROM HINGE FEMUR WAS IMPLANTED. TIBIAL COMPONENT WAS NOT REVISED. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16860375 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING INSTABILITY IN FLEXION AND EXTENSION. ALL SIGMA REVISION COMPONENTS WERE REMOVED AND AN ATTUNE KNEE REVISION WAS PUT IN. DOI: (B)(6) 2012, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10191049 ↗
• InjuryJun 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS INFECTED. ALL REVISION COMPONENTS WERE REMOVED AND ANTIBIOTIC SPACER WAS PUT IN. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10149198 ↗
• InjuryApr 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT LEFT ARTHROSCOPY AND DEBRIDEMENT FOR EXCESSIVE SCARRING, PAIN AND DECREASED ROM TO THE LEFT KNEE.

  Patient problems: Loss of Range of Motion; Pain; Scarring

  MAUDE report 8539329 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE 03 JAN 2019: ON (B)(6) 2014, 3 DAYS AFTER LEFT TKA REVISION, PATIENT DEVELOPED PULMONARY EDEMA AND CONGESTIVE HEART FAILURE WITH POSSIBLE MI. HE UNDERWENT A CABG X 5 FOR 3 VESSEL CARDIAC DISEASE ON (B)(6) 2014. PATIENT DEVELOPED BILATERAL PLEURAL EFFUSIONS AND INFECTION AFTER CABG REQUIRING STERNAL WOUND VAC AND IV ANTIBIOTIC ON (B)(6) 2014. DOI: (B)(6) 2014.

  Patient problems: Heart Failure; Myocardial Infarction; Pleural Effusion; Pulmonary Edema; Unspecified Infection

  MAUDE report 8537410 ↗
• InjuryFeb 6, 2019Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO FEMORAL COMPONENT MIGRATION; METAL / NICKEL ALLERGY.

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Pain

  MAUDE report 8311185 ↗
• InjuryFeb 6, 2019Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO FEMORAL COMPONENT MIGRATION; METAL/NICKEL ALLERGY.

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Pain

  MAUDE report 8311147 ↗