P.F.C. SIGMA 1581-13-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295063322), received between Jul 18, 2017 and Sep 26, 2024 — classified as 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 20314390 ↗
• 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 19174340 ↗
• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IRRIGATION AND DEBRIDEMENT (I&D), TIBIAL POLY AND PATELLA EXCHANGE WERE PERFORMED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17423581 ↗
• InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD REVISED TIBIAL POLY DUE TO POSSIBLE INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17071200 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAD HER KNEE REPLACED SOME TIME AGO BY SURGEON. THE EXACT DATE OF SURGERY IS UNKNOWN. THIS PATIENT CAME TO SEE SURGEON FOR INSTABILITY. THE DECISION WAS MADE TO REVISE THE KNEE KNEE TO MAKE IT MORE STABLE. A SIZE 3X12.5 CPD INSERT WAS EXOPLANETS AND A SIZE 3X15MM CVD PLUS WAS INSERTED AFTER TRIALING WHICH DEMONSTRATED IMPROVED STABILITY. THE PATELLA, TIBIAL TRAY, AND FEMUR WERE LEFT IN SITU. ACTIVITY LEVEL - YES. DOI: UNKNOWN, DOR:(B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16930889 ↗
• InjuryDec 15, 2021Naturally Worn; Naturally Worn

  PFC REVISION DUE TO CYST IN FEMORAL CONDYLE. THERE WAS WEAR ON THE INSERT WHEN REMOVED. THE PATIENT WAS ALSO UNSTABLE AND WAS ONE OF THE REASONS FOR REVISION.

  Patient problems: Joint Laxity

  MAUDE report 13011478 ↗
• MalfunctionSep 2, 2021Difficult to Insert; Difficult to Insert

  1. BASED ON THE EMAIL ATTACHED THE IMPLANT WAS NOT FITTING. CLARIFY WHAT DO YOU MEAN BY FITTING. WAS IT IMPLANT TO BONE FIT OR IMPLANT TO IMPLANT FIT? SURGEON REPORTED TO THE STAFF THAT THE TIBIAL INSERT WAS NOT ENGAGING WITH THE TIBIAL TRAY AND THEREFORE HAD TO OPEN A NEW TIBIAL INSERT. (IMPLANT TO IMPLANT FIT) 2. WAS SURGERY TIME EXTENDED? IF YES, WHAT WAS THE DURATION OF THE DELAY? YES, 15 MINUTES. 3. WAS THE REPORTED IMPLANT AVAILABLE FOR RETURN? YES. 4. PLEASE CLARIFY WHAT YOU MEAN BY "DESCRIPTION OF DAMAGE: PACKAGING - WRITTEN ON"? THIS WAS FOUND IN THE ATTACHED EXCEL FILE - (B)(4). I DON¿T KNOW WHAT THIS MEANS. 5. IMPLANT INSERTION OP NOTES:- PLEASE PROVIDE ALL NOTES RELEVANT TO THE REPORTED EVENT FOR EXAMPLE: - - REASON FOR IMPLANT INSERTION, DEVICE LABELS, SURGERY REPORT, PHYSIOTHERAPY REPORT, EARLY FALLS AND/OR DISLOCATIONS. NOT APPLICABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12413183 ↗
• InjurySep 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. THERE WAS NO WEAR PRESENT. NO OTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10568271 ↗
• InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS FLEXION AND EXTENSION INSTABILITY. REVISED FROM 8MM CURVED INSERT TO 12.5 CURVED PLUS. DOI: 2015; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9385173 ↗
• InjuryOct 9, 2019Naturally Worn; Naturally Worn

  DATE OF IMPLANTATION = APPROX 9 YEARS AGO.

  Patient problems: No Code Available

  MAUDE report 9171878 ↗
• InjuryJun 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SUB-ACUTE RESPIRATORY FAILURE W/BILATERAL PNEUMONIA: RESPIRATORY SYSTEM. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND PROBABLY RELATED TO PROCEDURE. DOI: (B)(6) 2013; DOR: (B)(6) 2018 (INSERT, PATELLA); DOE: (B)(6) 2018, (RIGHT KNEE).

  Patient problems: No Code Available; Pneumonia

  MAUDE report 8669952 ↗
• MalfunctionMay 7, 2019Naturally Worn; Naturally Worn

  CLINICAL ADVERSE EVENT RECEIVED FOR ABNORMAL X-RAYS - MODERATE LATERAL POLY WEAR : ABNORMAL RADIOGRAPHIC EVALUATION EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE EVENT IS DEFINITELY RELATED TO BOTH DEVICE AND PROCEDURE. DOI: (B)(6) 2006, DOE: (B)(6) 2019, (LEFT KNEE).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8587870 ↗
• InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF SIGMA PRIMARY KNEE-TEP AS PATIENT WAS SUFFERING PAIN SINCE PRIMARY IMPLANTATION. NO LOOSENING OF COMPONENTS. DOI: UNKNOWN, DOR: (B)(6) 2019. NO SURGERY DELAY REPORTED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8477552 ↗
• InjuryJul 24, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS ANTERIOR KNEE PAIN. DER ALSO INDICATES THAT THE SURGEON DOES NOT TYPICALLY RESURFACE PATELLA. PATELLA RESURFACED AND POLY EXCHANGE.

  Patient problems: Pain

  MAUDE report 6736629 ↗
• InjuryJul 18, 2017Naturally Worn; Naturally Worn

  PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE TIBIAL TRAY. THE INSERT WAS PITTING.

  Patient problems: Unspecified Infection

  MAUDE report 6721984 ↗

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-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-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-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-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-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-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-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-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-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-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-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.
• Z-1186-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 4, 12.5 mm; Ref 1581-24-012.
• Z-1160-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 3, 15 mm; Ref 1581-13-015.

…and 36 more.