P.F.C. SIGMA 96-2021Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10603295240679), received between Aug 30, 2017 and Sep 30, 2026 — classified as 30 injuries.

The most frequently reported specific device problem is “Naturally Worn” (11 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 30 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50950968 ↗
• InjuryDec 8, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION FOR POLY WEAR AND INSTABILITY. DOI: (B)(6) 2011. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23744639 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS LOOSE SO WENT UP TO A THICKER POLY. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 22592728 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - PE. DEVICE (RELATEDNESS): DEFINITELY NOT. PROCEDURE (RELATEDNESS): POSSIBLY. DATE OF EVENT: 28/AUG/2024 . DATE OF IMPLANT: INFORMATION NOT PROVIDED. DATE OF REVISION: INFORMATION NOT PROVIDED. DEVICE LOCATION: INFORMATION NOT PROVIDED. TREATMENT/IMPACT: PE.

  Patient problems: Pulmonary Embolism

  MAUDE report 20278589 ↗
• InjuryMay 22, 2024Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? - NO. C. CAN YOU CONFIRM IF THE PATELLA WAS REVISED AND IF SO, WHAT WAS THE FAILURE? - PATELLA WAS ADDED, NATURAL PATELLA WAS STILL INSITU.

  Patient problems: Discomfort; Pain

  MAUDE report 19374579 ↗
• InjuryFeb 16, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT SURGEON CHANGED POLY DUE TO WEAR. THERE WAS NO SURGICAL DELAY. DOR: 2002 AFFECTED SIDE: RIGHT KNEE

  Patient problems: Insufficient Information

  MAUDE report 18721750 ↗
• InjuryFeb 9, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO SECONDARY INSTABILITY DUE TO POLY WEAR. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18677241 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2022; DATE OF REVISION: (B)(6) 2023; (RIGHT KNEE). TREATMENT: FEMORAL COMPONENT, TIBIAL BASE, INSERT, AND PATELLA WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 18085664 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INCREASED PAIN AND INSTABILITY; TIBIAL LOOSENING. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2006. DATE OF REVISION: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: REVISION; TIBIAL BASE AND INSERT WERE REVISED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 17105121 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INCREASED PAIN AND INSTABILITY; MIGRATION/LOOSENING OF TIBIAL TRAY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2006. DATE OF REVISION: UNK. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: REVISION; TIBIAL TRAY AND INSERT WERE REVISED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16877918 ↗
• InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INCREASED PAIN AND INSTABILITY; MIGRATION/LOOSENING OF TIBIAL TRAY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2006. DATE OF EVENT: 27 APR 2023. (RIGHT KNEE). TREATMENT: REVISION; TIBIAL TRAY AND INSERT WERE REVISED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16876958 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2005. DATE OF REVISION: (B)(6) 2022. (RIGHT KNEE). TREATMENT: REVISION; INSERT WAS REVISED.

  Patient problems: Fall; Fever; Joint Laxity; Pain; Swelling/ Edema; Synovitis; Unspecified Infection

  MAUDE report 16145765 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR KNEE FLEXION INSTABILITY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2014; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15949144 ↗
• InjuryOct 12, 2022Naturally Worn; Naturally Worn

  PATIENT WAS REVISED WITH EXCHANGE OF INSERT DUE TO INSTABILITY. THE SIZED WAS UP FROM 0MM TO 12.5MM. NO SURGICAL DELAY WAS REPORTED. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15587673 ↗
• InjuryJul 1, 2022Adverse 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 VASCULAR DVT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE) . TREATMENT: ORAL MEDICATION (ELIQUIS X FOR 6 MONTHS) AND MONITORING BY PRIMARY PHYSICIAN.

  Patient problems: Discomfort; Joint Contracture; Muscular Rigidity; Pain; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 14886231 ↗
• InjuryJan 21, 2022Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS INSTABILITY (RELATED TO MCL INJURY). DATE OF IMPLANTATION: (B)(6) 2021; DATE OF REVISION: (B)(6) 2021; (LEFT KNEE). TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: Discomfort; Fall; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 13313954 ↗
• InjurySep 16, 2021Naturally Worn; Naturally Worn

  COMPASS CASE (B)(4) REPORTS: THE PATIENT WAS REVISED TO ADDRESS POLY WEAR. PATIENT WAS UNSTABLE. POSTERIOR MEDIAL POLY HAD SIGNIFICANT WEAR. ALL COMPONENTS WERE SOLID SO ONLY POLY WAS REVISED TO SAME THICKNESS. NO SURGICAL DELAY. DOI: (B)(6) 2005, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12482469 ↗
• InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2006 INDICATE THE PATIENT RECEIVED A BILATERAL TOTAL KNEE REPLACEMENTS DUE TO END STAGE OSTEOARTHRITIS. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. OFFICE NOTES (B)(6) 2021 INDICATE THE PATIENT IS EXPERIENCING BILATERAL KNEE PAIN AND SWELLING. RIGHT TOTAL KNEE REPLACEMENT HAS GLOBAL INSTABILITY. LEFT TOTAL KNEE REPLACEMENT WITH HAS INCREASED STIFFNESS AND DECREASED RANGE OF MOTION. LEFT KNEE WAS CAPTURED IN (B)(4). NO INTERVENTIONS NOTED AT THIS TIME. DATE OF IMPLANTATION: (B)(6) 2006, DATE OF EVENT (ONSET): (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity; Loss of Range of Motion; Muscular Rigidity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 12378109 ↗
• InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AND REVIEWED: (B)(6) 2021: CLINIC NOTE INDICATES THE PATIENT'S RIGHT KNEE IS PAIN, STIFF, SWOLLEN AND HAS BEEN EXPERIENCING DECREASED ROM. RADIOLOGY FILMS INDICATED GOOD CEMENT TO BONE AND IMPLANT TO CEMENT INTERFACES. THERE IS BONE BUILD-UP POSTERIORLY WHICH MAY BE PREVENTING SOME ROTATION. GLOBAL INSTABILITY IS ALSO NOTED. (B)(6) 2021: CLINICAL NOTE INDICATES SYNOVITIS IN THE RIGHT KNEE. (B)(6) 2021: PATIENT UNDERWENT A RIGHT KNEE REVISION. ADDITIONAL FINDINGS INCLUDE POLY WEAR OF THE PATELLA WITH DELAMINATION. NOTED TO MOST LIKELY BE CAUSE OF THE SYNOVITIS. TIBIAL TRAY AND PATELLA WERE REVISED. NO SIGNIFICANT WEAR WAS NOTED ON THE TIBIAL INSERT. RECORDS INDICATE THE PATIENT ALSO HAD A DEPUY LEFT KNEE REPLACEMENT ON (B)(6) 2006 (IMPLANTS INVOLVED INCLUDED ON THE 1ST PAGE OF THE FIRST OPERATIVE NOTE ATTACHMENT). DURING THE (B)(6) 2021 CLINIC VISIT STIFFNESS WAS NOTED. SYNOVITIS WAS NOTED ON THE (B)(6) 2021 CLINIC VISIT. AT THIS TIME THERE HAS BEEN NO INDICATION OF MEDICAL OR SURGICAL INTERVENTION OF THE LEFT KNEE.

  Patient problems: Joint Laxity; Loss of Range of Motion; Muscular Rigidity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 12331689 ↗
• InjuryJul 1, 2021Naturally Worn; Naturally Worn

  MAJOR ECCENTRIC WEAR OF THE POLYETHYLENE OF THE INSERT WITH MAJOR DYSFUNCTION OF THE PROSTHESIS WITH POSTERIOR SUBLUXATION OF THE PROSTHETIC CONDYLE. REOPERATION TO CHANGE THE INSERT. TREATMENT CONSISTED OF REVISION SURGERY WITH REMOVAL OF THE WORN TIP AND PLACEMENT OF A NEW TIP. DOI : (B)(6) 2008, DOE : (B)(6) 2021.

  Patient problems: Joint Laxity

  MAUDE report 12099801 ↗
• InjuryMay 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS TIGHT IN FLEXION. KNEE WAS REVISED. THE TIBIA AND TIBIAL INSERT ARE THE ONLY TWO COMPONENTS REMOVED FROM THE KNEE. REVISION IMPLANTS WERE THEN IMPLANTED. THERE IS NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 11864320 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS INSTABILITY. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF REVISION: (B)(6) 2020, (LEFT KNEE).

  Patient problems: Discomfort; Edema; No Code Available; Pain; Tissue Damage

  MAUDE report 9779353 ↗
• InjuryJan 8, 2020Naturally Worn; Unintended Movement; Naturally Worn; Unintended Movement

  IT WAS REPORTED THAT THE SURGEON STATED THAT THE KNEE WAS TIGHT IN THE MEDIAL COMPARTMENT AND LOOSE IN THE LATERAL CAUSING EXCESSIVE WEAR ON THE BEARING AND AN EVENTUAL SPIN OUT OF THE BEARING. DOI: (B)(6) 2009; DOR: (B)(6) 2019; UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available

  MAUDE report 9565881 ↗
• InjuryJun 24, 2019Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED DUE TO INSTABILITY AND POLY WEAR. NEW POLY IMPLANTED. DOI: 2009; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8727548 ↗
• InjuryJun 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION, I & D WITH INSERT EXCHANGE. DOI: UNK; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8678777 ↗