P.F.C. SIGMA 1581-24-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295064404), received between Nov 9, 2018 and Jun 30, 2025 — classified as 9 injuries, 4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT POLY WOULD NOT SNAP INTO TRAY. SURGEON OPENED TWO SIZE 4-8 POLY AND TWO SIZE 4 TRAYS AND BOTH POLY WOULD NOT SNAP INTO TO THE TRAY THAT WAS IMPLANTED AND THE EXTRA TRAY. DOE: (B)(6), 2025 AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22360017 ↗
• MalfunctionJun 30, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT POLY WOULD NOT SNAP INTO TRAY. SURGEON OPENED TWO SIZE 4-8 POLY AND TWO SIZE 4 TRAYS AND BOTH POLY WOULD NOT SNAP INTO TO THE TRAY THAT WAS IMPLANTED AND THE EXTRA TRAY. DOE: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359387 ↗
• MalfunctionNov 29, 2023Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT THERE WAS A BREACH IN THE SEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18226685 ↗
• InjuryOct 26, 2023Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO POLY WEAR. DOI: (B)(6) 2004. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18011133 ↗
• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. A WASHOUT AND A SIGMA POLY SWAP WERE DONE. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15486043 ↗
• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  KNEE REVISION FOR TIBIAL AND FEMORAL LOOSENING, KNEE PAIN AND STIFFNESS OF THE KNEE. LOOSENING AT THE CEMENT/ BONE INTERFACE WITH CEMENT NOT FROM DEPUY. SURGICAL TIME WAS NOT EXTENDED. TKA IMPLANTED IN 2008.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 12203788 ↗
• InjuryJun 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. NEW POLY IMPLANTED AND NO FURTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN DOR: (B)(6) 2021 LEFT KNEE.

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

  MAUDE report 11959735 ↗
• InjuryApr 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE WAS DIAGNOSED AS UNSTABLE. REMOVED ORIGINAL POLY (8MM) AND UP SIZED TO A 12.5 MM. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11675781 ↗
• InjuryDec 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. A POLY EXCHANGE WAS PERFORMED. NO OTHER INFORMATION WAS GIVEN AT THIS TIME. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

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

  MAUDE report 10976295 ↗
• MalfunctionNov 23, 2020Difficult to Insert; Difficult to Insert

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA TKA FOR THE PATIENT'S RIGHT KNEE JOINT. IT WAS REPORTED THAT DURING THE SURGERY, WHEN THE SURGEON IMPACTED THE TIBIAL INSERT, BUT THE TIBIAL INSERT DIDN'T FIT PROPERLY. THE SURGEON REMOVED THE TIBIAL INSERT ONCE WITH A EXTRACTOR, AND CHECKED, IMPACTED THE TIBIAL INSERT AGAIN. HOWEVER, THE TIBIAL INSERT WAS SEEMED BAD FIT. SO, THE SURGEON USED ONE SIZE LARGER TIBIAL INSET, IT FITTED CORRECTLY, THEN, THE SURGEON CLOSED INCISION. THE SURGERY WAS COMPLETED WITHIN 30 MINUTES DELAY. THE SURGEON COMMENTED THAT IT WAS UNKNOWN WHETHER PRODUCT DEFECT OR IMPACTING FAILURE. OTHER THAN THE SURGERY TIME'S A FEW MINUTES EXTENDED, THERE'S NO PARTICULAR HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 10885261 ↗
• InjuryJan 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PAINFUL LEFT KNEE. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2008. DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9580612 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REASON FOR REVISION: INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9401375 ↗
• InjuryNov 9, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INFECTED KNEE JOINT.

  Patient problems: Unspecified Infection

  MAUDE report 8056333 ↗

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-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-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-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-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-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-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-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-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-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-1187-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 15 mm; Ref 1581-24-015.
• Z-1178-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2.5, 10 mm; Ref 1581-22-010.
• Z-1157-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 2.5, 17.5 mm; Ref 1581-12-017.

…and 36 more.