P.F.C. SIGMA 1581-15-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295063575), received between Jul 24, 2019 and Jul 3, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION OF PFC DUE TO LYSIS AND INSTABILITY. WHEN THE KNEE WAS OPENED, THE POLYETHYLENE HAD SOME UNNATURAL WEAR AND SIGNS OF LYSIS. CR FEMUR, POLYETHYLENE AND FB BASE WERE REMOVED. MINIMAL BONE LOSS ON TIBIAL SIDE. SOME BONE LOSE ON FEMORAL SIDE WHICH BONE GRAFT WAS USED TO CORRECT. PT HAD MINIMAL SIGNS OF INFECTION SO PROCEEDED TO IMPLANT ATTUNE REVISION. GOOD STABILITY ATTAINED WITH STEMS AND SLEEVES BOTH SIDES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY.

  Patient problems: Joint Laxity; Osteolysis; Unspecified Infection

  MAUDE report 22398119 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ARTICLE ENTITLED ¿3D POLYETHYLENE WEAR ANALYSIS AFTER PRIMARY CRUCIATE-RETAINING TKA FAILURE USING OPTICAL SCANNING AND CAD MODELS REFERENCES¿ WRITTEN BY MATEJ VALIC, VESNA LEVA¿IC, INGRID MILO¿EV, MATEJA BLAS, EVA PODOV¿OVNIK, JAKA KOREN, AND RIHARD TREB¿E WAS REVIEWED. OUR PURPOSE WAS TO IDENTIFY (A) WHETHER VOLUMETRIC WEAR (ADJUSTED FOR TIME IN-SITU) SIGNIFICANTLY DIFFER AMONG GROUPS OF COMMON CAUSES OF TKA FAILURE, (B) WHETHER THERE IS A CHARACTERISTIC WEAR DISTRIBUTION PATTERN FOR A COMMON CAUSE OF TKA FAILURE, AND (C) WHETHER NOMINAL INSERT SIZE (SMALL VS LARGE) AND COMPONENTS SIZE RATIO (FEMUR-TO-INSERT) INFLUENCE ON VOLUMETRIC WEAR RATES. THE STUDY INCLUDED PATIENTS THAT HAD BEEN IMPLANTED WITH A SIGMA TKA (CEMENTED TIBIAL TRAY AND POROUS COATED FEMORAL COMPONENT). WITHIN THE PATIENT THAT MET THE CRITERIA, THERE WERE NOTED TO BE 86 REVISION CASES DUE TO FAILURE (NO MENTION OF WHY). 59/86 TIBIAL INSERTS WERE RETRIEVED. 2 OF THE 59 INSERTS EXHIBITED INEXPLICABLE ABNORMAL TYPE OF DAMAGE AND WERE EXCLUDED FROM THE FINAL ANALYSIS. FINAL COHORT INCLUDED 57 INSERTS. THERE WAS NO MENTION OF CEMENT MFG OR PATELLA IMPLANTS. RESULTS: 86 REVISIONS. ONLY 5 PATIENTS HAD A SINGLE DETECTED

  Patient problems: Unspecified Infection

  MAUDE report 19172227 ↗
• MalfunctionMar 14, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE INITIAL INSERT WOULD NOT SEAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537044 ↗
• InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY TOTAL KNEE REPLACEMENT SURGERY ON THEIR RIGHT KNEE ON (B)(6) 2011. PATIENT UNDERWENT A TWO-STAGE REVISION FOR INFECTION ON (B)(6) 2013. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2011. DOR: (B)(6) 2013. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16059889 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR POLY FAILURE, TIBIAL - WEAR. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2008. DATE OF EVENT (ONSET): (B)(6) 2020 (LEFT KNEE). TREATMENT: KNEE ASPIRATION - 30CC CLOUDY FLUID ASPIRATED AND SENT FOR ANALYSIS

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

  MAUDE report 11176094 ↗
• InjuryNov 9, 2020Naturally Worn; Naturally Worn

  AFFECTED SIDE IS LEFT.

  Patient problems: No Code Available

  MAUDE report 10810278 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENTS REVISED TO ADDRESS INFECTION OF THE KNEE. DOI: (B)(6) 2019. DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9569591 ↗
• InjuryJul 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY PROCEDURE WAS DONE ON THE (B)(6) 2009. PATIENT EXPERIENCED PAIN AND SWELLING, AND WAS SENT FOR OPEN EXPLORATION AND DEBRIDEMENT WITH POLY INSERT EXCHANGE. (B)(4).

  Patient problems: No Code Available; Pain; Swelling; Unspecified Infection

  MAUDE report 8822791 ↗

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-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-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-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-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-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-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-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-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-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-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-1176-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2, 20 mm; Ref 1581-21-020.
• Z-1191-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 5, 12.5 mm; Ref 1581-25-012.
• 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.

…and 36 more.