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P.F.C. SIGMA 1581-25-015Recalls & reported problems

Depuy (Ireland) · P.F.C. SIGMA TIBIAL INSERT FIXED BEARING STABILIZED 5 15mm GVF · Class 2 · Implant

All models of P.F.C. SIGMA (487)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295064602), received between Mar 31, 2022 and Mar 31, 2022 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Unspecified Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT WAS REVISED TO ADDRESS INFECTION OF RIGHT TOTAL KNEE I & D WASHOUT REMOVAL OF IMPLANTS. ANTIBIOTIC CEMENT SPACERS. DOI: (B)(6) 2017, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

    Patient problems: Unspecified Infection

    MAUDE report 13964453 ↗

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-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-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-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-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-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-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-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-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-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-1184-05 · May 26, 2005 · Terminated
    Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 8 mm; Ref 1581-24-008.
  • Z-1168-05 · May 26, 2005 · Terminated
    Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 10 mm; Ref 1581-15-010.

…and 36 more.

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

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