P.F.C. SIGMA 1581-50-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10603295064916), received between Aug 18, 2017 and May 11, 2026 — classified as 49 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (20 reports).

12 other recalls cover devices cleared under the same FDA submission (K032151, 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 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ADDITIONAL INFORMATION WAS RECEIVED STATED THAT: ONLY THE INSERT WAS REVISED, THE TIBIAL TRAY WAS NOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 25135119 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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; Unspecified Infection

  MAUDE report 22398193 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2008, THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY AND TIBIAL BONE GRAFT TO ADDRESS END-STAGE OSTEOARTHRITIS. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2018, THE PATIENT HAD A REVISION RIGHT TOTAL KNEE REPLACEMENT TIBIAL AND FEMORAL COMPONENT TO ADDRESS FAILED RIGHT TOTAL KNEE REPLACEMENT SECONDARY TO WEAR AND SYNOVITIS. THE INDICATIONS FOR SURGERY INCLUDED EPISODES OF RECURRENT SCAR FORMATION, WHICH REQUIRED EARLY MANIPULATION AND EXCISION. A REPEAT ARTHROSCOPIC EXCISION FOR SCAR TISSUE AND THEN UNDERSIDE OF THE QUAD TENDON AND NOW WITH RECURRENT STIFFNESS AND SWELLING. RADIOGRAPHS WERE REPORTED TO SHOW A RADIOLUCENT LINE AROUND THE FEMORAL COMPONENT. DURING THE PROCEDURE, THE SURGEON OBSERVED THE POLYETHYLENE HAD BOTH FRONT SIDE AND BACKSIDE WEAR. THE SIGMA PFC KNEE HAD A RELATIVELY HIGH DEGREE OF POSTERIOR SLOPE ON THE TIBIAL SIDE AND THE FEMORAL IMPLANT DID NOT HAVE GROSS MOTION BUT WAS RELATIVELY EASY TO REMOVE AFTER BREAKING UP THE INTERFACES WITH MINIMAL BONE INGROWTH INTO THE INGROWTH SURFACES ON THE BACKSIDE OF THE IMPLANT. IT WAS NOTED THAT THE BACKSIDE OF THE IMPLANTS HAVE SMALL AREAS OF SPOT WELDING, BUT THE REMAI

  Patient problems: Adhesion(s); Muscular Rigidity; Swelling/ Edema; Synovitis

  MAUDE report 22123533 ↗
• InjuryMay 8, 2025Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT PATIENT COMPLAINED OF KNEE PAIN. UPON REVIEW ON X-RAY, TIBIAL COMPONENT LOOKED LOOSE AND SLIGHTLY COLLAPSED INTO VARUS. THERE WAS SIGNIFICANT WEAR AROUND THE FEMUR AS WELL. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. DOI: (B)(6) 2011. DOR: (B)(6) 2025. AFFECTED AREA: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21988214 ↗
• InjuryApr 25, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: LOOSE (UNKNOWN COMPONENT OR INTERFACE) AND PAIN

  Patient problems: Pain

  MAUDE report 19180963 ↗
• InjuryApr 24, 2024Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; 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 19172292 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 18977324 ↗
• InjuryMar 25, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR (B)(6) 2023. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: "LOOSE PAIN "

  Patient problems: Insufficient Information

  MAUDE report 18967557 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE : UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18441021 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO LOOSENING. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17395559 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO RESECTION FOR INFECTION. IT WAS GROUP B STREP. ACTIVITY LEVEL WAS YES. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16921011 ↗
• InjuryFeb 20, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE FEMUR AND TIBIA AT THE CEMENT TO IMPLANT INTERFACE. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2012, DOR: (B)(6) 2023, AND AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16404759 ↗
• MalfunctionFeb 17, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE PRODUCT IN QUESTION IS WITH THE NATIONALIZATION LABEL WITH INCORRECT INFORMATION. TOTAL OF 10 UNITS: EXTERNAL NATIONALIZATION LABELS ARE DESCRIBED AS PFC SIGMA INSTRUMENT KIT INSTEAD OF PFC SIGMA KNEE IMPLANT, AS PER PHYSICAL PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16395939 ↗
• MalfunctionFeb 15, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE PRODUCT IN QUESTION IS WITH THE NATIONALIZATION LABEL WITH INCORRECT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16382867 ↗
• MalfunctionFeb 15, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE PRODUCT IN QUESTION IS WITH THE NATIONALIZATION LABEL WITH INCORRECT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16382507 ↗
• MalfunctionFeb 15, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE PRODUCT IN QUESTION IS WITH THE NATIONALIZATION LABEL WITH INCORRECT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16382488 ↗
• MalfunctionFeb 15, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE PRODUCT IN QUESTION IS WITH THE NATIONALIZATION LABEL WITH INCORRECT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16382473 ↗
• MalfunctionFeb 15, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE PRODUCT IN QUESTION IS WITH THE NATIONALIZATION LABEL WITH INCORRECT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16382461 ↗
• MalfunctionFeb 15, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE PRODUCT IN QUESTION IS WITH THE NATIONALIZATION LABEL WITH INCORRECT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16382448 ↗
• MalfunctionFeb 15, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE PRODUCT IN QUESTION IS WITH THE NATIONALIZATION LABEL WITH INCORRECT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16382437 ↗
• MalfunctionFeb 15, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE PRODUCT IN QUESTION IS WITH THE NATIONALIZATION LABEL WITH INCORRECT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16382405 ↗
• MalfunctionFeb 15, 2023Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE PRODUCT IN QUESTION IS WITH THE NATIONALIZATION LABEL WITH INCORRECT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16382383 ↗
• MalfunctionFeb 4, 2023Wrong Label; Wrong Label

  WE HAVE RECEIVED A CUSTOMER COMPLAINT THAT ANVISA'S REGISTER (B)(4) IS LABELED NOT TO MATCHING THE PRODUCT. THE LABEL MENTIONS "INSTRUMENTAL KIT....NON-STERILE-STERILIZE PRODUCT BEFORE USE", HOWEVER THE PRODUCT IS ALREADY STERILE.

  Patient problems: Insufficient Information

  MAUDE report 16301922 ↗
• MalfunctionFeb 4, 2023Wrong Label; Wrong Label

  WE HAVE RECEIVED A CUSTOMER COMPLAINT THAT ANVISA'S REGISTER (B)(4) IS LABELED NOT TO MATCHING THE PRODUCT. THE LABEL MENTIONS "INSTRUMENTAL KIT....NON-STERILE-STERILIZE PRODUCT BEFORE USE", HOWEVER THE PRODUCT IS ALREADY STERILE.

  Patient problems: Insufficient Information

  MAUDE report 16301919 ↗
• 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 16059906 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032151, K241000. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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-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-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-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-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-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