P.F.C. SIGMA 1581-14-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295063445), received between Sep 22, 2017 and Apr 24, 2024 — classified as 12 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 17 most recent of 17 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; Loss of Range of Motion; Unspecified Infection

  MAUDE report 19174326 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INSTABILITY. INSERT WAS REVISED TO A LARGER SIZE. DOI: UNKNOWN. DOR: (B)(6), 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14490643 ↗
• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS A LITTLE UNSTABLE AS PER THE SURGEON. THE SURGEON UPSIZED THE POLY. THERE WAS NO SURGICAL DELAY. LEFT EXISTING COMPONENTS 96-0005 L-D19123106, 96-0103 L-9518016, AND 158140000 L-9466790. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13523602 ↗
• MalfunctionNov 17, 2021Difficult to Insert; Material Integrity Problem; Difficult to Insert; Material Integrity Problem

  IT WAS REPORTED THAT ONE OF THE TWO ANTERIOR 'PHALANGES' HAD BENT AND THEREFORE IT WAS NOT POSSIBLE TO ENGAGE THE TIBIAL TRAY. THERE WAS A SURGICAL DELAY OF A FEW MINUTES. NO PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 12828327 ↗
• InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  1.IT WAS INDICATED IN THE EVENT DESCRIPTION THAT ALL COMPONENTS APPEARED WELL FIXED BUT IT ALSO STATED THAT, "THERE WAS LITTLE IF ANY BONEY INGROWTH INTO THE POROUS COATING" WHEN THE FEMUR WAS REMOVED. PLEASE CLARIFY IF THERE WAS LOOSENING INVOLVED IN THIS EVENT. ANSWER: THE FEMORAL COMPONENT APPEARED WELL FIXED AND WAS NOT OVERTLY LOOSE ¿ NO MOVEMENT WAS DETECTED ¿ WHEN THE SURGEON WORKED AROUND THE FEMUR TO FREE THE FEMORAL COMPONENT ¿ THE FEMUR FINALLY WAS REMOVED AND THE UNDERSIDE OF THE FEMUR EXAMINED ¿ THE POROCOAT DID NOT SHOW ANY SIGNS OF BONEY INGROWTH, BUT RATHER A FIBROUS TISSUE INGROWTH ¿ SO I CAN ASSUME THEN THAT THE FEMUR MY HAVE BEEN LOOSE FROM THE TIME OF THE ORIGINAL INDEX REVISION AND THAT THE FIBROUS TISSUE INGROWTH WAS THE RESULT! 2. IT WAS REPORTED THAT THE KNEE HAS BEEN SCOPED IN THE PAST AND THAT SAMPLES WERE TAKEN. PLEASE VERIFY IF ANY OF THE PRODUCTS WERE REVISED/EXPLANTED DURING THIS EVENT. ANSWER: NO, NO IMPLANTS WERE REVISED AND AT THIS STAGE, AND I WAS NOT MADE AWARE OF THE SCOPE PROCEDURE. 3. WAS THE CEMENT PRODUCT MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE QUANTITY, PART AND LOT NUMBERS OF THE CEMENT. ANSWER: NO, THE CEMENT WAS NOT A DEPUY PROD

  Patient problems: Adhesion(s); Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 11995831 ↗
• MalfunctionNov 23, 2020Fracture; Fracture

  INTRAOPERATIVELY DURING IMPACTION OF THE INLAY INTO THE TIBIAL PLATEAU THE CIRCUMFERENTIAL PE LIP OF THE INLAY ON THE BOTTOM BROKE OFF. NO ADVERSE PATIENT CONSEQUENCE REPORTED, NO SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10885991 ↗
• InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS RANGE OF MOTION. FEMORAL COMPONENT WAS REVISED. COULD NOT READ LOT CODE ON FEMUR IMPLANT. NO SURGICAL DELAY. DOI: (B)(6) 2012; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 10858128 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2010, THE PATIENT HAD A RIGHT TOTAL KNEE TO ADDRESS OSTEOARTHRITIS. DEPUY COMPONENTS INCLUDING DEPUY PATELLA AND DEPUY CEMENT X1 WERE UTILIZED. THERE WERE NO COMPLICATIONS NOTED IN THE SURGICAL NOTES. ON (B)(6) 2013, THE PATIENT HAD AN ARTHROSCOPIC EXCISION OF SCAR TISSUE WITH MANIPULATION OF STIFF RIGHT KNEE AND PAIN.

  Patient problems: Adhesion(s); Muscular Rigidity; No Code Available; Pain

  MAUDE report 9849908 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT KNEE TO ADDRESS FLEXION INSTABILITY DATE OF IMPLANTATION: (B)(6) 2014; DATE OF REVISION: (B)(6) 2015; (RIGHT KNEE). TREATMENT: FEMUR AND TIBIAL INSERT REVISED

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9813381 ↗
• InjuryMar 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POLYETHYLENE EXCHANGE WAS PERFORMED DUE TO HEMATOMA. DOI: (B)(6) 2017. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: Hematoma; No Code Available

  MAUDE report 9777183 ↗
• InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS LAXITY AND INSTABILITY. THE SURGEON CHANGED THE INSERT TO A THICKER POLY AND CURVED PLUS INSERT. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9682649 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT KNEE REV - ORIGINAL SURGERY DONE (B)(6) 2014. IRRIGATION AND DEBRIDEMENT TO DEAL WITH INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9207738 ↗
• MalfunctionMay 16, 2019Naturally Worn; Naturally Worn

  SUBJECT ID: (B)(6). DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR ABNORMAL X-RAYS - FEMORAL LUCENCIES. FOLLOWUP MEDICAL RECORD REVIEW REVEALED OFFICE NOTES (B)(6) 2019 INDICATES THE PATIENT IS EXPERIENCING MINIMAL PAIN. RADIOGRAPHS REVEAL LUCENCY UNDERNEATH THE MEDIAL TIBIAL PLATEAU ON THE LEFT SIDE. POLYWEAR IS ALSO NOTED.

  Patient problems: Pain

  MAUDE report 8615346 ↗
• MalfunctionApr 30, 2019Naturally Worn; Naturally Worn

  CLINICAL ADVERSE EVENT RECEIVED FOR ABNORMAL X-RAYS - FEMORAL LUCENCIES, TIBIAL AP LUCENCIES, POLYWEAR EVENT IS NOT SERIOUS AND IS CONSIDERED MILD EVENT IS DEFINITELY RELATED TO BOTH DEVICE AND PROCEDURE. DOI: (B)(6) 2008, DOE: (B)(6) 2019, (LEFT KNEE).

  Patient problems: No Consequences Or Impact To Patient; Pain

  MAUDE report 8564201 ↗
• MalfunctionApr 10, 2019Difficult to Insert; Fitting Problem; Device Damaged Prior to Use; Difficult to Insert; Fitting Problem; Device Damaged Prior to Use

  10 MINS ADDED ON TO TIME OF SURGERY. THIS WAS DUE TO DOUBLE CHECKING FIRST IMPLANT AND THEN COLLECTING SECOND FROM STORE ROOM.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 8501215 ↗
• InjuryJul 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. WASHOUT WAS PERFORMED AND POLY INSERT WAS REPLACED. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7694793 ↗
• InjurySep 22, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY.

  Patient problems: Pain

  MAUDE report 6886395 ↗

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-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-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-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-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-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-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-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-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-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-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-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-1171-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 17.5 mm; Ref 1581-15-017.
• Z-1170-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 15 mm; Ref 1581-15-015.
• Z-1173-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 1.5, 8 mm; Ref 1581-20-008.

…and 36 more.