P.F.C. SIGMA 96-2122Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295241188), received between Sep 14, 2017 and Apr 15, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Fracture

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO POLY FRACTURE ON SIGMA PS RP INSERT 2.5 10MM. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24885240 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A SURGERY 3 WEEKS PRIOR AND DEVELOPED A INFECTION IN HER KNEE. ORIGINAL IMPLANT DATE (B)(6) 2012. NO DELAY IN SURGERY. DR PERFORMED A WASHOUT ON HER KNEE AND REPLACED POLY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21596864 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INFECTION. THERE WAS A LOOSENING REPORTED AT THE TIBIA AT CEMENT TO IMPLANT INTERFACE. DOI: (B)(6) 2019, DOR: (B)(6) 2023, AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18426161 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WENT TO THE SURGEON DUE TO PAIN AND INSTABILITY OF THE LEFT KNEE. UPON PHYSICAL EXAM SURGEON NOTED INSTABILITY IN THE KNEE JOINT. X-RAY OF THE LEFT KNEE SHOWED SUBSIDENCE OF THE MEDIAL SIDE OF THE TIBIAL COMPONENT. DURING THE SURGERY IT WAS NOTED THAT THE FEMUR WAS WELL FIXED. THE TIBIAL COMPONENT WAS LOOSE AT THE CEMENT TO IMPLANT INTERFACE. CEMENT WAS FIXED TO THE BONE BUT NO CEMENT CAME OUT WITH THE TIBIAL COMPONENT. DEPUY CEMENT WAS USED. ATTUNE REVISION COMPONENTS WERE USED FOR THE SURGERY. ONCE COMPONENTS WERE IMPLANTED, IT WAS NOTED THAT THE KNEE WAS STABLE AND HAD GREAT RANGE OF MOTION. DOI: (B)(6) 2016, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 17743895 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 15310722 ↗
• InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO SCAR TISSUE EXCISION AND POLY EXCHANGE. NO ADDITIONAL INFORMATION. DOI : UNKNOWN, DOR : (B)(6) 2022, LEFT SIDE.

  Patient problems: Scar Tissue

  MAUDE report 13341691 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. FEMUR WAS LOOSE AT THE CEMENT TO BONE INTERPHASE AND THE TIBIA WAS LOOSE AT THE CEMENT TO IMPLANT INTERPHASE. UNKNOWN BONE CEMENT WAS USED. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2018, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11921105 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD SKIN ISSUE AND HAD HER PATELLA IMPLANT PROTRUDING EXTERNALLY. ALL IMPLANTS FOUND TO BE LOOSE AND WERE REPLACED.

  Patient problems: Joint Laxity; Wound Dehiscence

  MAUDE report 11843429 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATED THE FOLLOWING: QUESTION: 1. THE EVENT DESCRIPTION INDICATED THAT THE SURGEON FOUND SOME CEMENT DEBRIS THAT HAD BEEN LEFT FROM THE PREVIOUS SURGEON. WAS THE CEMENT PRODUCT MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE QUANTITY, PART AND LOT NUMBERS OF THE CEMENT. 2. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? 3. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? 4. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? 5. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY. RESPONSE; 1. UNKNOWN, 2. NO, 3. NO, 4. NO, 5. NO.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11837884 ↗
• InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE IMPLANTS WERE REMOVED DUE TO KNEE STIFFNESS.

  Patient problems: Muscular Rigidity; No Code Available

  MAUDE report 10465827 ↗
• InjuryJun 8, 2020Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Unstable; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS UNSTABLE KNEE. THEY WENT UP TO 2 INSERT SIZES. DOI: (B)(6) 2009. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10130204 ↗
• InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: (B)(6) 2007. DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9787880 ↗
• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE 02-NOV-2018: PATIENT UNDERWENT A RIGHT SIGMA TKA ON (B)(6) 2016. ON (B)(6) 2016, PATIENT REPORTING PAIN, STIFFNESS, SWELLING AND THE RIGHT KNEE ¿NOT WORKING PROPERLY.¿ SHE WAS ULTIMATELY REVISED ON (B)(6) 2018 FOR ASEPTIC LOOSENING OF THE TIBIAL TRAY AT THE DEVICE-CEMENT INTERFACE. THE PATELLA WAS NOT REVISED. DOI: (B)(6) 2016; DOR: (B)(6) 2018.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Edema; Erythema; Fall; Joint Contracture; Limited Mobility Of The Implanted Joint; Muscular Rigidity; No Code Available; Pain; Rash; Weakness

  MAUDE report 9557573 ↗
• InjuryDec 13, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 8162161 ↗
• InjuryNov 26, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8102567 ↗
• InjuryMar 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT KNEE REVISION DONE BY DR. (B)(6) ON (B)(6) 2018. PATIENT EXPERIENCED SOME KNEE INSTABILITY AND ASSOCIATED PAIN. REMOVED THE POLY INSERT AND REPLACED WITH A THICKER POLY. NO SURGICAL DELAY - NO BROKEN INSTRUMENTS. PATIENT CONSEQUENCE?: UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

  Patient problems: Pain

  MAUDE report 7330595 ↗
• InjuryOct 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND PATELLA ISSUES.

  Patient problems: Pain

  MAUDE report 6948802 ↗
• InjurySep 14, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6865626 ↗