P.F.C. SIGMA 1581-15-012Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295063599), received between Jul 20, 2018 and Dec 28, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER SURGERY ON (B)(6) 2020, PATIENT COMPLAINS OF STIFF JOINT (B)(6) 2021. NO IMPROVEMENT IN JOINT STIFFNESS AFTER MOBILIZATION UNDER ANESTHESIA (B)(6) 2021. PATIENT COMPLAINS OF SWELLING AFTER A FALL (B)(6) 2022. (B)(6) 2022 INFECTION IS DETECTED. EXPLANATION OF KNEE PROSTHESIS ON (B)(6) 2022 AND IMPLANTATION OF CEMENT SPACER. REVISION OPERATION ON (B)(6) 2022.

  Patient problems: Fall; Muscular Rigidity; Swelling/ Edema; Unspecified Infection

  MAUDE report 18415709 ↗
• InjuryJul 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7707520 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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.
• Z-1159-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 3, 10 mm; Ref 1581-13-010.
• 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.

…and 36 more.