P.F.C. SIGMA 95-1040Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295230410), received between Sep 22, 2017 and Oct 29, 2024 — classified as 17 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2024Naturally Worn; Naturally Worn

  REVISION OF A PFC SIGMA. REASON FOR REVISION WAS DUE TO POLY WEAR. FEMORAL, TIBIAL, AND PATELLA IMPLANTS WERE NOT REVISES AS THEY WERE WELL FIXED. POLY DEBRIS WAS REMOVED AND THE AREA WAS THOROUGHLY CLEANED. NO INDICATION OF WEAR ON THE FEMORAL OR TIBIAL COMPONENTS. PATIENT LEFT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 20558651 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNKNOWN DEFECT OCCURRED. WE ARE CONFIRMING ABOUT DETAILS. ADDITIONAL EVENT INFORMATION: IT WAS REPORTED THAT ON AN UNKNOWN DATE (ABOUT 15 YEARS AGO), THE PATIENT UNDERWENT THE PRIMARY SURGERY WITH THE INSERT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. DATE UNKNOWN, BUT THE INSERT IN QUESTION WAS REMOVED DUE TO INFECTION. THE NEW INSERTS WERE NOT REPLACED BECAUSE THE PROCEDURE WAS PERFORMED USING A CEMENT MOLD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 19701160 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2005. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18247507 ↗
• InjuryMay 10, 2023Naturally Worn; Naturally Worn

  SURGEON WILL PROBABLY ORDER A PATIENT SPECIFIC PE INLAY FOR A PLANNED REVISION OF KNEE-PE-INLAY RIGHT SIDE. DOI: > 7 YRS AGO. DOR: PLANNED AS SOON AS PATIENT SPECIFIC PE IMPLANT WILL BE MANUFACTURED BY DEPUY IN SPRING/SUMMER 2023. THERE HAS BEEN NO ALLEGATION OF ANY PRODUCT DEFICIENCY.

  Patient problems: Insufficient Information

  MAUDE report 16901564 ↗
• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2022. UNKNOWN KNEE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 15040833 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 13688862 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT THE PRIMARY TKA SURGERY WITH THE INSERT IN QUESTION. AFTER THE SURGERY, REVISION SURGERY WAS PERFORMED DUE TO PROSTHETIC JOINT INFECTION ON (B)(6) 2022. IN THE REVISION SURGERY, THE SURGEON REPLACED THE NEW INSERT AFTER DEBRIDEMENT. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2010, DOR: (B)(6) 2022, UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13498027 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE, DECREASED RANGE OF MOTION : ADHESIONS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2015. DATE OF EVENT (ONSET): (B)(6) 2016. (LEFT KNEE). TREATMENT: LEFT KNEE MANIPULATION UNDER ANESTHESIA.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 13288711 ↗
• InjuryJan 18, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTED LEFT TOTAL KNEE REPLACEMENT INFECTION - DEEP. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2015; DATE OF EVENT (ONSET): (B)(6) 2015; (LEFT KNEE). TREATMENT: ON (B)(6) 2015, REVISION OF FEMUR, TIBIAL TRAY, AND INSERT; PATELLA COMPONENT WAS RETAINED.

  Patient problems: Joint Dislocation; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 13282986 ↗
• InjuryDec 9, 2021Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INSTABILITY WAS DUE TO WEAR OVER TIME. KNEE HAD BEEN IN AT LEAST 15 YEARS. NO MALPOSITION OF IMPLANTS AND NO IMPLANTS WERE UNDERSIZED. JOINT LINE WAS NOT RAISED.

  Patient problems: Joint Laxity

  MAUDE report 12967738 ↗
• InjuryNov 15, 2021Naturally Worn; Unintended Movement; Naturally Worn; Unintended Movement

  REVISION OF A SIGMA PFC PS RP TOTAL KNEE. REASON FOR REVISION WAS DUE TO POLY SPIN OUT. THIS OCCURRED APPROXIMATELY 1 YEAR AGO. THE PRIMARY SURGERY WAS DONE ON (B)(6) 2005. MALE, RIGHT SIDE. THE 10MM POLY WAS REMOVED AND WE THEN TRIALED AND IMPLANTED A 12.5MM POLY. DOI: (B)(6) 2005, DOR: APPROX. ONE YEAR AGO, RIGHT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 12813014 ↗
• InjuryAug 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR CREPITUS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS PROBABLY RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY EVENT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2012, DATE OF EVENT (ONSET): (B)(6) 2013, (LEFT KNEE). TREATMENT: SURGICAL INTERVENTION - ARTHROSCOPY (NO PRODUCTS REVISED).

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

  MAUDE report 12278617 ↗
• InjuryMar 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: (B)(6). ASSOCIATED STUDY: (B)(6). DATE OF EVALUATION: (B)(6) 2013. DATE OF ONSET: (B)(6) 2013. OPERATIVE SIDE: RIGHT. DIAGNOSIS: DEEP INFECTION INVOLVING KNEE PROSTHESIS DUE TO GROUP G STREPTOCOCCUS & SUPERFICIAL CELLULITIS. ADVERSE EVENT: INFECTION - DEEP. SPECIFY: COUNTRY: (B)(6). SERIOUS: YES. DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: DEFINITELY NOT. SUBJECT'S AGE AT ENROLLMENT: (B)(6). SUBJECT'S AGE AT DATE OF SURGERY: (B)(6). SUBJECT'S GENDER: FEMALE. SUBJECT'S HEIGHT: 154 CM. SUBJECT'S WEIGHT: (B)(6) KG.

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

  MAUDE report 11392873 ↗
• InjuryFeb 26, 2021Noise, Audible; Noise, Audible

  STUDY: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR CREPITUS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2012. DATE OF EVENT (ONSET): (B)(6) 2014. (LEFT KNEE). TREATMENT: ARTHROSCOPY ON (B)(6) 2014

  Patient problems: Insufficient Information

  MAUDE report 11388761 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION - DEEP. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: 09/15/2015, DATE OF EVENT (ONSET): 09/03/2015, (LEFT KNEE). TREATMENT: REVISED ON (B)(6) 2015, ALL DEPUY PRODUCTS EXPLANTED.

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

  MAUDE report 11373619 ↗
• InjuryOct 13, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THERE WAS A WEAR IN THE POLYETHYLENE. DOI: (B)(6) 2009; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10673593 ↗
• InjurySep 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6887325 ↗