P.F.C. SIGMA 1581-21-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295063926), received between Dec 12, 2017 and Aug 20, 2025 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT VOLUNTARY REPORT WAS RECEIVED (B)(4). ORIGINAL SURGERY DATE FOR RIGHT TOTAL KNEE ARTHROPLASTY (B)(6) 2021. PATIENT REQUIRED A KNEE REPLACEMENT 6/18/2025. WHEN THE OLD KNEE REPLACEMENT WAS REMOVED, THERE WAS SIGNIFICANT DAMAGE TO THE JOINT WHICH WAS NOT EXPECTED AND SEEMED TO BE A MANUFACTURING DEFECT. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Musculoskeletal problem

  MAUDE report 22849162 ↗
• MalfunctionMay 23, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THE INSERT COULDN¿T BE INSERTED INTO THE JOINT OR THE TIBIAL TRAY. THERE WERE NO PATIENT CONSEQUENCES. IT WAS CONFIRMED THERE WAS NO ISSUE WITH THE TIBIAL TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078797 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO TIGHT IN EXTENSION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 20021369 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2008, THE PATIENT UNDERWENT THE SURGERY FOR THE KNEE WITH THE INSERT. AFTER THE SURGERY, INFECTION OCCURRED, AND REPLACEMENT OF THE INSERT BECAME NECESSARY. ON (B)(6) 2021, THE PATIENT UNDERWENT THE REVISION SURGERY, AND THE SURGEON PERFORMED DEBRIDEMENT AND REPLACED THE INSERT. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS EVENT HAS BEEN REPORTED IN (B)(4), (B)(4). AFTER THIS EVENT, THE SURGEON REPORTED THAT THE SYMPTOMS OF INFECTION HAVE NOT RESOLVED ON (B)(6) 2022. THE SURGEON COMMENTED THAT HE WOULD NOT CHANGE THE IMPLANT AGAIN BUT PERFORM ARTHROSCOPIC SURGERY THIS EVENT HAS BEEN REPORTED IN (B)(4),(B)(4). AFTER THIS EVENT, IT WAS REPORTED THAT THE SURGEON PERFORMS DEBRIDEMENT AND REPLACES THE INSERT IN QUESTION ON (B)(6) 2023 FOR THE LEFT PYOGENIC ARTHRITIS. MEDICAL HISTORY: RHEUMATOID ARTHRITIS NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 16994169 ↗
• MalfunctionNov 8, 2022Difficult to Insert; Device Damaged Prior to Use; Difficult to Insert; Device Damaged Prior to Use

  UNABLE TO ASSEMBLE. THE PATIENT UNDERWENT KNEE ARTHROPLASTY ON (B)(6) 2022. DURING THE SURGERY, IT WAS FOUND THAT THE BACKSIDE OF THE INSERT HAS THE PROTRUDING PROBLEM, WHICH RESULTED IN THAT THE INSERT COULD NOT BE IMPLANTED WITH THE TIBIAL PLATEAU. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THIS RESULTED IN A 2 MM INCREASE IN PATIENT BONE CUTOFF. THE PATIENT WAS IN STABLE CONDITION NOW. RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 15751926 ↗
• MalfunctionJul 22, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE INSERT IS DIFFICULT TO ASSEMBLE TO TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15087639 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. NEW POLY IMPLANTED. NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14604999 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED TO ADDRESS PAIN DUE TO OVERSTUFFED TIBIAL IMPLANT. ISSUE WAS WITH THE SIZING OF THE IMPLANT. NO LOOSENING WAS PRESENT.

  Patient problems: Pain

  MAUDE report 14196701 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  REVISION COMPLETED DUE TO INFECTION. DEBRIDEMENT WAS PERFORMED AND INSERT WAS REPLACED. SURGEON REPORTED SIGNS OF INFECTION PERSISTED AFTER PROCEDURE AND EXPRESSED DESIRE TO PERFORM ARTHROSCOPIC SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 13498406 ↗
• MalfunctionFeb 7, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS A SURGICAL DELAY OF 30 MINS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8316733 ↗
• MalfunctionFeb 7, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS A SURGICAL DELAY OF 30 MINS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8316728 ↗
• InjuryDec 12, 2017Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS SUBSIDENCE. IT WAS ALSO STATED THAT THERE WAS A TIBIAL CYST AND MEDIAL WEAR. DOI:(B)(6) 2013; DOR: (B)(6) 2017; UNKNOWN KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7108953 ↗

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-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-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-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-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-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-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-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-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-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-1179-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2.5, 12.5 mm; Ref 1581-22-012.
• Z-1190-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 5, 10 mm; Ref 1581-25-010.

…and 36 more.