P.F.C. SIGMA 1581-21-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295063933), received between Mar 2, 2018 and Mar 2, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 reports).

51 other recalls cover devices cleared under the same FDA submission (K033272, K241000); they may or may not involve this specific model.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED REVISION SURGERY OCCURRED DUE TO PFC INFECTION WITH SIGNS OF UNSEALING. PROCEDURE COMPLETED WITH NO SURGICAL DELAY. PRIMARY TKA: (B)(6) 2006 (PROF. FRITSCHY). REVISION: (B)(6) 2026 (DR THIBAULT FAVRE). SIDE: LEFT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 24483478 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INSTABILITY OF PREVIOUS IMPLANTS. REMOVED OLD IMPLANTS AND REVISED WITH NEW. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24245739 ↗
• InjuryMar 21, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2022 PATIENT CAME TO (B)(6) SEEKING FOR HELP DUE TO UNSTABLE RIGHT KNEE. PATIENT HAD A TOTAL KNEE REPLACEMENT (BILATERAL) BACK IN (B)(6) 2018 AT (B)(6) WITH THE SAME SURGEON. SYSTEM USED WAS PFC IMPLANTS. SURGEON SUSPECTED IS THE IMPLANT INSERT (POLYETHYLENE) ISSUE. HENCE, CONTACTED ME AND ARRANGED FOR A CHANGE OF INSERT PROCEDURE THE NEXT DAY. (B)(6) 2022 SURGEON ABLE TO CONFIRM IT IS THE ISSUE OF IMPLANT INSERT AFTER EXPOSING THE RIGHT KNEE AND HENCE, DID A CHANGE OF INSERT PROCEDURE. SURGEON COMMENTED PFC IMPLANTS SUPPOSED TO LAST AT LEAST 20YRS AS PER THE CLINICAL PAPERS. PATIENT HAD THE BILATERAL TKR PROCEDURE ONLY 4YRS AGO. DOI: (B)(6) 2018; DOR: (B)(6) 2022; RIGHT KNEE.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 13840668 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2021 DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13620987 ↗
• MalfunctionAug 4, 2021Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT AND THE AFFECTED SIDE WAS THE LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12273833 ↗
• MalfunctionMar 7, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE LOCKING CLIP THAT SECURES THE FIXED BEARING POLY INSERT INTO THE SIGMA FIXED BEARING TIBIA TRAY MALFUNCTIONED AND WOULD NOT LET THE INSERT SEAT SECURELY. PRODUCT WAS DISCARDED AND WILL NOT BE RETURNED. DOE: (B)(6) 2021, UNKNOWN KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11426700 ↗
• InjuryMar 2, 2018Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS UNSTABLE KNEE AND POSTERIOR MEDIAL WEAR. REVISED TO 12.5 INSERT FROM 10 MM. DOI: (B)(6) 2000; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7309096 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033272, K241000. One submission often covers many models, so check the product and lot details in each record.

• Z-0414-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or defin
• Z-0413-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or def
• Z-0419-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive
• Z-0415-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or
• Z-0416-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or d
• Z-0421-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or defin
• Z-0422-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definit
• Z-0412-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or de
• Z-0423-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definit
• Z-0417-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or de
• Z-0420-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive
• Z-0418-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definiti
• Z-1154-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 2, 8 mm; Ref 1581-11-008.
• Z-1155-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert , Sz 2.5, 8 mm; Ref 1581-12-008.
• Z-1192-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 5, 22.5 mm; Ref 1581-25-022.

…and 36 more.