P.F.C. SIGMA 1581-25-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295064572), received between Sep 20, 2018 and Dec 3, 2021 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED KNEE. SWAPPED POLY FOR WASHOUT PURPOSES ONLY. DOI: (B)(6) 2015. DOR: (B)(6), 2021. LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12927284 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. THE SURGEON INCREASED POLY THICKNESS FROM 8MM TO 12.5MM AND WAS HAPPY WITH KNEE STABILITY. THERE WERE NO DEFICIENCIES NOTED WITH THE PRODUCT AND NO DELAY IN PROCEDURE. LOT NUMBER WAS NOT LEGIBLE AND POLY WILL NOT BE AVAILABLE FOR RETURN SINCE IT WAS DISPOSED OF BY HOSPITAL. DOI: UNKNOWN. DOR: (B)(6) 2021. (LEFT KNEE).

  Patient problems: Joint Laxity

  MAUDE report 12618053 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. THE SURGEON INCREASED POLY THICKNESS FROM 8MM TO 12.5MM AND WAS HAPPY WITH KNEE STABILITY. THERE WERE NO DEFICIENCIES NOTED WITH THE PRODUCT AND NO DELAY IN PROCEDURE. LOT NUMBER WAS NOT LEGIBLE AND POLY WILL NOT BE AVAILABLE FOR RETURN SINCE IT WAS DISPOSED OF BY HOSPITAL. DOI: UNKNOWN - DOR: (B)(6) 2021 (LEFT KNEE).

  Patient problems: Joint Laxity

  MAUDE report 12617549 ↗
• InjuryFeb 10, 2021Adverse 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) 2011. DATE OF REVISION: (B)(6) 2020. (RIGHT KNEE). TREATMENT: REVISION OF TOTAL KNEE CONSTRUCT.

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

  MAUDE report 11311613 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. ALL COMPONENTS REMOVED. DOI: (B)(6) 2011. DOR: (B)(6) 2020; RIGHT KNEE.

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

  MAUDE report 11107790 ↗
• InjuryJun 10, 2019Fracture; Fracture

  THE PATIENT WAS REVISED DUE TO INSTABILITY, THE STABILIZED INSERT'S POST WAS BROKEN OFF, SO ONLY THE INSERT WAS EXCHANGED. DOI: (B)(6) 2006. DOR: MAY 21, 2019. RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 8683285 ↗
• MalfunctionFeb 6, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THE LOCKING MECHANISM DID NOT ENGAGE WITH THE TIBIAL TRAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8310931 ↗
• InjuryDec 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO INFECTED LEFT KNEE JOINT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8151615 ↗
• InjurySep 20, 2018Naturally Worn; Naturally Worn

  PT HAD INSERT AND PATELLA LEFT KNEE REVISED FOR POLY WEAR. ORIGINAL DOS 20 YEARS AGO. PATIENT CONSEQUENCE? :YES PATIENT CONSEQUENCE DESCRIPTION:PATIENT NEEDED REVISION SURGERY FOR EXCESSIVE POLY WEAR. ACTION TAKEN FOR PROCEDURE:INSERT POLY EXCHANGE AND REVISED PATELLA COMPONENT IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Not Applicable

  MAUDE report 7896607 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-1156-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 2.5, 10 mm; Ref 1581-12-010.
• Z-1166-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 4, 17.5 mm; Ref 1581-14-017.
• Z-1180-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 3, 10 mm; Ref 1581-23-010.

…and 36 more.