SIGMA 1960-00-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295074762), received between Feb 5, 2018 and Jul 10, 2025 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

8 other recalls cover devices cleared under the same FDA submission (K241000, K943462); 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.

• InjuryJul 10, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT PRESENTED IN THE CLINIC DUE TO PAIN. LEFT KNEE TKA HAD BEEN DONE ON (B)(6) 2012. XRAY REVEALED RADIOLUCENT LOOSENING OF LEFT CR FEMUR ANTERIORLY AT CEMENT TO IMPLANT INTERFACE. PATIENT WAS BROUGHT IN FOR REVISION.

  Patient problems: Pain

  MAUDE report 22470413 ↗
• InjuryApr 24, 2024Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device 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: Pain

  MAUDE report 19172266 ↗
• InjuryFeb 22, 2024Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO BROKEN DISTAL FEMUR. THE SURGEON EXPLANTED A SIGMA CR FEMUR WITH ALL POLY TIBIA AND IMPLANTED A LPS FEMUR WITH ATT REV TIBIA. DOI: (B)(6) 2015. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Bone Fracture(s); Insufficient Information

  MAUDE report 18758947 ↗
• InjuryMay 23, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  CLINICAL ADVERSE EVENT RECEIVED FOR ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2013. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL BASE, AND INSERT WERE REVISED.

  Patient problems: Insufficient Information

  MAUDE report 16985815 ↗
• InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANTS REMOVED AND REVISED DUE TO PAIN AND SWELLING IN THE FEMUR AND TIBIA. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 16598886 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A NICKEL ALLERGY AND REACTED TO THE IMPLANT. DR. REMOVED THE IMPLANT AND REPLACED WITH AESCULAP. DOI- UNKNOWN. DOR- (B)(6) 2022. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 15987033 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR CALF PAIN, VASCULAR DEEP VEIN THROMBOSIS - LEFT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. TREATMENT: ORAL MEDICATION ELIQUIS.

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 14488032 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION OF IMPLANT DUE TO INFECTION AND DID A ONE STAGE REVISION. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12562725 ↗
• InjuryAug 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FALL AND TORE HER MEDIAL COLLATERAL LIGAMENT. SURGEON TOOK OUT FEMUR AND INSERT. SURGEON PUT IN POSTERIOR STABILIZED INSERT. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: Fall; Injury; No Code Available

  MAUDE report 10453858 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION TOTAL KNEE REPLACEMENT: PROSTHESIS IMPLANTED WITH CONSTRAINED TO PROMOTE STABILITY. ORIGINAL OXFORD UNICOMPARTMENTAL KNEE (ZIMMER BIOMET) REVISED TO PFC TKR USING PRIMARY CR FEMORAL COMPONENT AND CR RP CURVED BEARING. TIBIA MBT REVISION TIBIA AND STEP WEDGE AND STEM TO COUNTER FOR BONE LOSS ASSOCIATED WITH THE OXFORD UNICOMPARTMENTAL KNEE. PATELLA RESURFACED AT TIME OF SURGERY TO A PFC OVAL DOME PATELLA WHICH REMAINS IN SITU. THE PATIENT EXPERIENCING INSTABILITY AND FEMORAL COMPONENT AND BEARING REVISED TO A PFC TC3 RP FEMORAL COMPONENT AND TC3 RP BEARING TO PROMOTE STABILITY.

  Patient problems: No Code Available

  MAUDE report 9742019 ↗
• MalfunctionJan 21, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING THE CASE ON 2.5 SIZER CAME OUT OF THE 4 SIZER BOX. THE (B)(4) CODED DEVICE WAS IN CONSIGNMENT. IT'S UNKNOWN HOW THE PROCEDURE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8264581 ↗
• InjuryMay 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENTS KNEE WAS REVISED DUE TO PAIN IN THE TIBIA SUFFERED AFTER A HARD FALL. THE TIBIAL COMPONENT WAS TAKEN OUT WITH SOME FORCE NEEDS LEAVING CEMENT ON THE TRAY AND IN THE TIBIA. DOI: (B)(6) 2017 DOR: (B)(6) 2018 LEFT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7529216 ↗
• InjuryFeb 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN WITH STIFFNESS. DOI: (B)(6) 2014, DOR: (B)(6) 2018, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 7240598 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, K943462. One submission often covers many models, so check the product and lot details in each record.

• Z-1077-2014 · Dec 9, 2013 · Terminated
  PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.
• Z-1686-2009 · May 7, 2009 · Terminated
  DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retaining Femoral Component, 73 mm M/L 69 mm A/P, 5 left, sterile, DePuy Orthopaedics, Inc., Warsaw, IN; REF 96-0005. The devic
• Z-0407-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 5, 15mm, 83mm M/L, 55mm A/P, UHMWPE, sterile; Product Code/REF 96-0663.
• Z-0402-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 2.5, 8 mm, 67mm M/L, 45 mm A/P, UHMWPE, 2.5, sterile; Product Code/REF 96-0630.
• Z-0406-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 4, 10mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0651.
• Z-0404-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 3, 10mm, 71mm M/L, 47mm A/P, UHMWPE, sterile; Product Code/REF 96-0641.
• Z-0403-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 3, 8 mm, 71mm M/L, 47 mm A/P, UHMWPE, sterile; Product Code/ REF 96-0640.
• Z-0405-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 4, 8mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0650.