P.F.C. SIGMA 1581-15-112Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295063650), received between Feb 5, 2020 and Jul 12, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2023Adverse 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 A PATELLAR DISLOCATION BUT ALSO SLIGHT ANTERIOR TRANSLATION OF THE TIBIA ON THE FEMUR. DOI: 2008; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17312165 ↗
• InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY EXCHANGE WAS DONE. NO SURGICAL DELAY WAS REPORTED. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15827119 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 15240444 ↗
• InjuryMar 7, 2022Naturally Worn; Naturally Worn

  PATIENT UNDERWENT A RIGHT MEDIAL UNICOMPARTMENTAL KNEE REPLACEMENT MANY YEARS AGO (NOT A DEPUY IMPLANT). A NUMBER OF YEARS LATER THE PATIENT PRESENTED WITH A BROKEN TIBIAL COMPONENT. AT THIS TIME IN 2015, THE UNICOMPARTMENTAL KNEE REPLACEMENT WAS REVISED TO A PRIMARY PFC FEMORAL COMPONENT WITH A STEMMED TIBIAL COMPONENT (DEPUY CEMENT WAS NOT UTILISED) . THE MEDIAL SIDE OF THE TIBIA WAS BONE GRAFTED WITH AN AUTOGRAFT AND HELD IN PLACE WITH TWO K WIRES. APPROXIMATELY 3 YEARS AFTER THIS "REVISION" THE PATIENT REPORTS HAVING BEEN HIT/ RAMMED BY A COW AND EXPERIENCED SOME FORM OF TRAUMA AROUND THE MEDIAL ASPECT OF THE RIGHT KNEE. PATIENT HAS HAD PROGRESSIVELY INCREASING PAIN, VERY SPECIFICALLY AROUND THE MEDIAL EPICONDYLE OF THE FEMUR. A DECISION WAS MADE TO OPEN THE KNEE AND INVESTIGATE THE CAUSE AND TO LOOK TO CHANGE THE BEARING. ON OPENING THE KNEE, THE SYNOVIAL FLUID WAS FOUND TO BE BLOOD STAINED. THERE ALSO APPEARED TO BE TRACES OF BLACKENED METALOSIS (THIS HAS BEEN ATTRIBUTED TO THE ORIGINAL UNI KNEE WHICH HAD BROKEN AS NO METAL ON METAL ARTICULATION WAS EVIDENT) A BONEY SPUR WAS EVIDENT AROUND THE MEDIAL EPICONDYLE AND THERE APPEARED TO BE WEAR TO THE POLY BEARING IN THE AREAS WH

  Patient problems: Hematoma; Joint Laxity; Pain; Unspecified Musculoskeletal problem

  MAUDE report 13684375 ↗
• InjuryOct 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME TO HOSPITAL WITH SWELLING AND PAIN OF THE AFFECTED KNEE. I & D LINER EXCHANGE WAS DONE. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 12711648 ↗
• InjurySep 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR STATED KNEE WAS INFECTED. REMOVED POLY, WASHED OUT, NEW POLY PUT IN. ORIGINAL IMPLANT DATE IS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10555793 ↗
• InjuryFeb 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. THE CR PRESS FIT SIGMA FEMUR AND POLY WERE REMOVED AND REPLACED WITH A TC3 FEMUR AND FB TC3 POLY. DOI: (B)(6) 2008. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9671487 ↗