P.F.C. SIGMA 1581-12-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295063209), received between Nov 22, 2017 and Apr 24, 2024 — classified as 8 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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: Joint Laxity; Unspecified Infection

  MAUDE report 19174344 ↗
• MalfunctionAug 30, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING IMPLANTATION, SURGEON STRUGGLED TO LOCK THE INSERT INTO TIBIAL TRAY. ANOTHER INSERT WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17649724 ↗
• InjurySep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY WAS REVISED DUE TO POSSIBLE INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15445509 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAD THEIR KNEE DONE BY A SURGEON SOMETIME IN 2006, EXACT DATE UNKNOWN. SURGEON WAS NOT SURE OF THE EXACT DATE OF THEIR INITIAL PROCEDURE. PATIENT WAS SUFFERING FROM SOME INSTABILITY IN THEIR KNEE. SURGEON FELT THE PATIENT WOULD BENEFIT FROM A POLY EXCHANGE FROM THE CVD INSERT TO A CVD PLUS INSERT. AN SIZE 2.5 8MM INSERT WAS REMOVED AND TRIAL REDUCTIONS WERE PERFORMED WITH THE 12.5 AND 15MM CVD PLUS INSERTS. SURGEON FELT THE 15MM PROVIDED THE BEST STABILITY. THE REAL IMPLANT WAS OPENED AND INSERTED. THE LEG WAS RUN THROUGH A FULL RANGE OF MOTION AND FOUND TO BE SATISFACTORY AND CLOSING PROCESS BEGAN. DOI: 2006, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12359458 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS TO CAPTURE THE REPORTED EVENT IN (B)(4). OFFICE NOTES INDICATE THE PATIENT EXPERIENCED AN ACUTE POSTOPERATIVE PERIPROSTHETIC JOINT INFECTION WAS TREATED WITH IRRIGATION DEBRIDEMENT ABOUT 2 MONTHS POSTOPERATIVELY FROM HER PRIMARY IN (B)(6) 2011.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10720634 ↗
• InjuryMay 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION TOTAL KNEE REPLACEMENT: THE PATIENT PRESENTED TO THE SURGEON WITH A PAINFUL KNEE. BONE SCAN SHOWED THE FEMUR AND PATELLA WERE LOOSE. INFECTION MARKERS ALL WITHIN NORMAL RANGE. WHEN IMPLANTS WERE REMOVED THERE WERE SIGNS OF OSTEOLYSIS BEHIND THE FEMORAL COMPONENT CENTRAL TO THE ANTERIOR CHAMFER REGION. NO OBVIOUS SIGNS OF OSTEOLYSIS ON THE POLY OF THE INSERT OR PATELLA. PHOTOS TAKEN OF IMPLANTS. IMPLANTS DISCARDED. NO AE REPORTED. NO DELAY IN THE SURGERY.

  Patient problems: No Code Available; Osteolysis; Pain

  MAUDE report 10075196 ↗
• InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR OSTEOLYSIS : ABNORMAL RADIOGRAPHIC EVALUATION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE, EVENT IS DEFINITELY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2005, DATE OF REVISION: (B)(6) 2015, DATE OF EVENT: (B)(6) 2019, (LEFT KNEE).

  Patient problems: No Code Available; Osteolysis

  MAUDE report 9612201 ↗
• MalfunctionAug 26, 2019Difficult to Insert; Difficult to Insert

  COMPLAINT FROM (B)(6) HOSPITAL, REGARDING A SIZE 2.5 / 8 MM SIGMA, FIXED BEARING, CURVED IMPLANT. SURGEON UNABLE TO INSERT 2.5 8 MM POLY ONTO TIBAL TRAY. DEFECT ON UNDERSIDE OF THE POLY NOTED BY SURGEON. REPLACEMENT POLY USED INSTEAD.

  Patient problems: Not Applicable

  MAUDE report 8930184 ↗
• InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF THE RIGHT KNEE FOR PAIN, INSTABILITY, AND STIFFNESS. COMPETITOR BONE CEMENT WAS USED AT PRIMARY.

  Patient problems: No Code Available; Pain

  MAUDE report 8655630 ↗
• MalfunctionMar 20, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  SURGEON UNABLE TO IMPACT A TIBIAL INSERT INTO THE TRAY, DURING A KNEE REPLACEMENT. THE SURGERY WAS A PRIMARY KNEE REPLACEMENT. THE ITEM WAS A SIGMA CURVED TIBIAL INSERT REF: 158112008. FURTHER CLARIFICATION STATED THAT THE SURGEON WAS UNABLE TO IMPACT IT, AND ON INSPECTION IT LOOKED LIKE THE INSERT WAS DAMAGED. ANOTHER INSERT OF THE SAME SIZE WAS OPENED AND IMPACTED SUCCESSFULLY.

  Patient problems: Not Applicable

  MAUDE report 8437372 ↗
• MalfunctionDec 4, 2018Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  PRODUCT IS BROKEN.

  Patient problems: Not Applicable

  MAUDE report 8129751 ↗
• MalfunctionNov 2, 2018Break; Break

  INTRAOPERATIVELY IT WAS NOT POSSIBLE TO FIX THE INLAY ON THE TIBIAL PLATEAU.

  Patient problems: Not Applicable

  MAUDE report 8033407 ↗
• InjuryNov 22, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CLINICAL DER STATES THAT AN AE RECEIVED FOR ADHESIONS - ARTHROFIBROSIS. INITIAL TREATMENT INCLUDES CLOSED REDUCTION AND MANIPULATION. REVISION OF DEPUY INSERT OCCURRED DUE TO PAIN AND STIFFNESS.

  Patient problems: Adhesion(s); Fibrosis; Pain

  MAUDE report 7053850 ↗

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-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-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-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-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-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-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-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-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-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-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-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-1165-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 4, 15 mm; Ref 1581-14-015.
• Z-1188-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 17.5 mm; Ref 1581-24-017.

…and 36 more.