P.F.C. SIGMA 96-2041Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10603295240815), received between Sep 7, 2017 and Jun 26, 2026 — classified as 50 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (13 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 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. POLY SWAP AND I&D WAS PERFORMED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25634329 ↗
• InjuryDec 4, 2025Adverse 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 INFECTION. I&D POLY EXCHANGE. THERE WAS NO ADDITIONAL INFORMATION. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23716094 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED AS THE OLD FEMORAL IMPLANT HAD BECOME INFECTED. THERE WAS LOOSENING OF THE FEMUR AND TIBIAL IMPLANTS AT THE BONE/CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOCTOR REMOVED OLD IMPLANTS. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22072322 ↗
• InjuryMar 26, 2025Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED DUE TO POLY WAS WORN OUT POSTERIORLY. THE SURGICAL DELAY IS UNKNOWN. DOI: (B)(6) 2005. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21700207 ↗
• InjuryOct 11, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT TIBIAL POLY INSERT HAD SIGNIFICANT WEAR ON POSTERIOR MEDIAL SIDE OF THE POLY. PATELLA HAD STARTED TO DELAMINATE AND COULD NOT BE SALVAGED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20426816 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2004. DATE OF REVISION: UNK. DATE OF EVENT: (B)(6) 2024. (RIGHT KNEE). TREATMENT: REVISION; INSERT WAS REVISED.

  Patient problems: Joint Laxity

  MAUDE report 19632947 ↗
• InjuryJun 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT POLY AND PATELLA WERE SWAPPED DUE TO WEAR. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19491851 ↗
• InjuryApr 23, 2024Naturally Worn; Naturally Worn

  STUDY NO: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO POLY WEAR, PAIN AND STIFFNESS. DATE OF IMPLANT: (B)(6) 2007. DATE OF REVISION: (B)(6) 2024. (RIGHT KNEE). TREATMENT: INSERT WAS REVISED.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 19165622 ↗
• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD REVISION DUE TO NATIVE PATELLA NOT DONE DURING PRIMARY TOTAL KNEE. RESURFACE PATELLA AND CHANGED POLY. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18777958 ↗
• InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2017; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 18580695 ↗
• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POLY EXCHANGE FOR INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18287981 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD LYSIS FROM LOOSENING OF LEFT FEMUR AT BONE TO CEMENT INTERFACE. FEMUR AND POLY WERE EXPLANTED. TC3 FEMUR WAS IMPLANTED WITH RPPS POLY. SURGICAL DELAY IS UNKNOWN.

  Patient problems: Osteolysis

  MAUDE report 17367750 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2011. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE. THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 16875765 ↗
• InjuryMar 27, 2023Unintended Movement; No Apparent Adverse Event; Unintended Movement; No Apparent Adverse Event

  CLINICAL ADVERSE EVENT RECEIVED FOR SPIN OUT. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023. DATE OF REVISION: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: REVISION; INSERT WAS REVISED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618165 ↗
• InjuryMar 24, 2023Naturally Worn; Naturally Worn

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN AND EFFUSION; POSSIBLE MICROMOTION DUE TO POLY WEAR EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2008. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: REVISION; INSERT WAS REVISED. ASPIRATION FOR CULTURES AFTER D/C OF ANTIBIOTICS FOR SINUS INFECTION.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 16609245 ↗
• InjuryMar 23, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PATIENT WAS SENT TO THE HOSPITAL WITH AN RPCR INSERT THAT HAD SPUN OUT. DOCTOR OPENED THE PATIENT UP AND REPLACED THE POLY AFTER CHECKING THE BALANCE OF THE KNEE. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16598953 ↗
• InjuryJan 26, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  ON (B)(6) 2002, PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT TO ADDRESS PAIN AND A SEVERE POSTEROLATERAL DEPRESSION OF THE TIBIAL PLATEAU FROM FRACTURE MALUNION. PATIENT HAD NO COMPLICATIONS. ON (B)(6) 2023, PATIENT'S RIGHT KNEE WAS REVISED TO ADDRESS GROSS FAILURE OF THE POLYETHYLENE, WITH SYMPTOMS OF PAIN, SWELLING, INSTABILITY AND INSERT ISSUES. IT WAS FOUND THAT FEMUR AND TIBIAL TRAY COMPONENTS ARE WELL-FIXED. THE INSERT WAS FOUND TO BE WORN, DELAMINATED, AND FRACTURED AT THE MEDIAL POSTERIOR LIP. THE PATELLA WAS FOUND TO NOT BE SIGNIFICANTLY WORN AND WAS RETAINED.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 16246346 ↗
• InjuryJan 26, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD POSTERIOR LATERAL WEAR, PAIN, INSTABILITY FOR ABOUT 2-3 YEARS. MAY HAVE BEEN RESULT OF A PREVIOUS FALL. DOI: 2008. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Joint Laxity; Pain

  MAUDE report 16246288 ↗
• InjuryOct 27, 2022Fracture; Naturally Worn; Fracture; Naturally Worn

  PFC SIGMA CURVED LEFT CEMENTED. INSERT BROOKEN ON THE BACK DUE TO WEAR. LOSENING OF TIBIA. METALOSE.

  Patient problems: Discomfort; Foreign Body Reaction; Insufficient Information; Joint Laxity; Pain

  MAUDE report 15681099 ↗
• InjurySep 15, 2022Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO WEAR ON THE INSERT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2018, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15428511 ↗
• InjuryNov 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY REPORTED AND THE PATELLA WAS AN IMPLANT.

  Patient problems: Osteolysis

  MAUDE report 12750688 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12533817 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORT: REVISED DUE TO PAIN. NO SURGICAL DELAY. DOI: (B)(6) 2020.

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

  MAUDE report 12466727 ↗
• InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND BONY LOSS ON TIBIA. NO LOOSENING REPORTED AND NO SURGICAL DELAY. DOI: (B)(6) 2013. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12454638 ↗
• InjuryAug 17, 2021Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS POSTERIOR LATERAL POLY WEAR. PATIENT HAD PAIN IN HER LATERAL KNEE. DISCOVERED THE POLY HAD BEEN WORN IN THE POSTERIOR LATERAL ASPECT WHICH LIKELY KEPT THE ROTATION POLY FROM MOVING. DOI: (B)(6) 2011, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12330837 ↗