P.F.C. SIGMA 1581-14-108Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295063506), received between Jul 20, 2017 and Jun 9, 2026 — classified as 12 injuries, 2 malfunctions.

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTED RIGHT KNEE. INCISION AND DRAINAGE. INSERT EXCHANGE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25446558 ↗
• InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 21 SEP 2022. MEDICAL RECORDS ((B)(4) MEDICAL RECORDS AD 21 SEP 2022) REVIEWED: ON (B)(6) 2017, PATIENT RECEIVED A CEMENTED LEFT CRUTIATE RETAINING TOTAL KNEE REPLACEMENT TO ADDRESS OSTEOARTHRITIS. THE PROCEDURE WAS PERFORMED WITH NO IDENTIFIED COMPLICATIONS. ON (B)(6) 2020, PATIENT'S LEFT KNEE WAS REVISED TO ADDRESS CHRONIC LEFT KNEE PAIN AND INSTABILITY. SIGNIFICANT KNEE EFFUSION WAS IDENTIFIED INTRAOPERATIVELY, AND SYNOVIAL EROSIONS IN THE SOFT TISSUES AROUND THE TIBIAL TRAY IMPLANT. THE TIBIAL TRAY, FEMUR, AND PATELLA IMPLANTS WERE ALL WELL-FIXED. A THICKER INSERT WAS PUT IN PLACE OF THE REVISED PRIMARY INSERT; ALL OTHER IMPLANTS WERE RETAINED. NO COMPLICATIONS WERE REPORTED. DOI: (B)(6) 2017. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 15562183 ↗
• MalfunctionFeb 14, 2022Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE CUSTOMERS RECEIVED AN IMPLANT IN DECEMBER (SHIPPED FROM EDC ON (B)(6) 2021), WHICH EXPIRED ONLY 3 WEEKS LATER, ON DECEMBER 31ST, 2021. UNFORTUNATELY THIS IMPLANT WAS USED IN SURGERY YESTERDAY, ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13522800 ↗
• MalfunctionJun 15, 2021Fracture; Fracture

  IT WAS REPORTED THAT INSERT CHIPPED WHILE BEING INSERTED WITH TEFLON MALLET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12001751 ↗
• InjuryJun 11, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT DURING PT, INSERT POPPED OUT AND BACK IN. THE PATIENT WAS EXPERIENCING SLIGHT DISCOMFORT THAT LED TO THE REVISION SURGERY.

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

  MAUDE report 11983417 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL RIGHT KNEE. TIBIAL INSERT EXCHANGE WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10482699 ↗
• InjuryJun 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS STIFFNESS. THE 8MM CURVED INSERT WAS CHANGED TO AN 8MM CURVED PLUS. A PCL RELEASE AND AN IT BAND RELEASE WERE PERFORMED. DOI: (B)(6) 2018; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Muscular Rigidity; No Code Available

  MAUDE report 10173649 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED ON AD 27 FEB 2020 WERE REVIEWED ON AD (B)(6) 2020 BY A CLINICIAN TO IDENTIFY PRODUCT ISSUES AND/OR PATIENT HARMS. PATIENT RECEIVED LEFT PRIMARY PFC SIGMA TKA TO TREAT DEGENERATIVE JOINT DISEASE OF THE LEFT KNEE. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT REPORTED COMPLICATIONS. PRIMARY IMPLANT STICKER SHEET IS AVAILABLE ON PAGE 11 OF THE MEDICAL RECORDS. ON (B)(6) 2014, THE PATIENT SENT A LETTER TO DEPUY WITH COMPLAINTS OF A ¿SNAPPING¿ IN THE KNEE JOINT WHEN MOVING. ON (B)(6) 2020, THE PATIENT SENT A LETTER TO DEPUY WITH COMPLAINTS OF PAIN, EMOTIONAL DISTRESS, AND, ¿BEING RESTRICTED IN WHAT AND HOW¿ HE COULD ACCOMPLISH DAILY TASKS. RECORDS INDICATE THE PATIENT WAS REVISED DUE TO PAIN. UPON ENTERING THE KNEE, THE SURGEON IDENTIFIED AND EXCISED PERICAPSULAR SCAR TISSUE BEFORE REMOVING THE TIBIAL INSERT. THE FEMORAL COMPONENT, PATELLA, AND TIBIA WERE ALL REVISED DUE TO LOOSENING AT AN UNKNOWN INTERFACE. THE PATIENT WAS THEN IMPLANTED WITH DEPUY REVISION KNEE COMPONENTS UTILIZING UNKNOWN CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Adhesion(s); Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9780281 ↗
• InjuryFeb 27, 2020Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth; Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth

  PATIENT CORRESPONDENCE: PATIENT CONTACTED DEPUY STATING HE IS EXPERIENCING "SNAPPING" AT HIS KNEE JOINT WHEN WALKING AND WHEN RAISING HIS LEG.

  Patient problems: Adhesion(s); Fall; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9767463 ↗
• InjuryFeb 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND EXCESS FLUID. DEBRIDEMENT AND SOFT TISSUE RELEASE WERE PERFORMED AND EXCHANGED INSERT TO CURVED PLUS SAME THICKNESS. DOI: (B)(6) 2017; DOR: (B)(6) 2019; LEFT SIDE.

  Patient problems: No Code Available; Pain

  MAUDE report 9673214 ↗
• InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY, SURGEON REMOVED AN 8 MM POLY AND INCREASED TO A 10 MM BEARING TO HELP MAKE THE PATIENTS KNEE STABLE. DOI: (B)(6) 2016; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9224501 ↗
• InjuryMar 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8381646 ↗
• InjuryOct 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS STAPH INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7980656 ↗
• InjuryJul 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL DER STATES THAT PATIENT HAD AN INFECTION. EVENT MEETS THE DEFINITION OF SERIOUS. EVENT IS NOTED TO BE NOT RELATED TO DEVICE.

  Patient problems: Unspecified Infection

  MAUDE report 6727460 ↗