SIGMA 96-0008Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10603295232001), received between Oct 25, 2017 and Sep 23, 2024 — classified as 25 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).

16 other recalls cover devices cleared under the same FDA submission (K241000, K943462, K952830); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - PE DEVICE (RELATEDNESS): DEFINITELY NOT PROCEDURE (RELATEDNESS): POSSIBLY DATE OF EVENT: (B)(6) 2024 DATE OF IMPLANT: INFORMATION NOT PROVIDED DATE OF REVISION: INFORMATION NOT PROVIDED DEVICE LOCATION: INFORMATION NOT PROVIDED TREATMENT/IMPACT: PE.

  Patient problems: Pulmonary Embolism

  MAUDE report 20278582 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT'S KNEE WAS REVISED DUE TO INSTABILITY. THE PATIENT'S PRIMARY SIGMA FIXED BEARING CRUCIATE RETAINING COMPONENTS (INSERT, TIBIAL TRAY, AND FEMUR) WERE REMOVED AND REPLACED BY ATTUNE REVISION COMPONENTS. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2022 DOR- (B)(6), 2024 AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20157551 ↗
• InjuryApr 19, 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 19144892 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO NICKEL ALLERGY. DEVICES ARE REMOVED. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. (B)(6). AFFECTED SIDE: LEFT

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18383004 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 2008 IMPLANTED SIGMA PFC KNEE PROSTHESIS HAD TO BE REVISED, DUE TO PAIN. THERE WAS SOME "METALLOSE" IN THE KNEE JOINT. IT WAS REPLACED WITH AN ATTUNE REVISION PROSTHESIS. DOI: 2008 DOR: (B)(6) 2023 UNKNOWN KNEE.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 16712666 ↗
• InjuryFeb 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: ARTHROSCOPY.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 16301909 ↗
• InjurySep 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SPIN OUT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2022, DATE OF EVENT (ONSET): (B)(6) 2022, (LEFT KNEE). TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 15464466 ↗
• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022 THE PATIENT HAD A LEFT TOTAL CEMENTED KNEE ARTHROPLASTY TO ADDRESS END-STAGE ARTHROSIS. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT WERE USED DURING THIS PROCEDURE. 08/16/2022 MEDICAL RECORDS NOTE THE PATIENT IS STATUS POST LEFT KNEE REPLACEMENT WITH NEW ONSET PAIN AND POPPING. INITIAL SURGERY WAS 5 MONTHS AGO, THEN THE PATIENT WAS SEPTIC POSTOPERATIVELY AND PNEUMONIA AS WELL AS C. DIFFICILE. IT WAS NOTED ON PHYSICAL EXAMINATION THAT THE PATIENT HAS LOTS OF VALGUS LAXITY. THE IMPRESSION IS THAT THE PATIENT HAS STATUS POST LEFT KNEE REPLACEMENT WITH MCL INJURY AND LIKELY SPINNING OUT OF POLY.

  Patient problems: Pneumonia; Unspecified Infection

  MAUDE report 15455669 ↗
• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AS COMPLAINANT HAD TOTAL KNEE REPLACEMENT APPROXIMATELY 7 YEARS AGO AND SUFFERED SINCE THEN AND WAS RECENTLY DIAGNOSED WITH PROGRESSIVE BREAST CANCER. "I BELIEVE THERE IS A CORRELATION BETWEEN THE METALS IN THE REPLACEMENT PARTS AND MY PROGRESSIVE BREAST CANCER. I AM HIGHLY ALLERGIC TO NICKEL AND SENSITIVE TO CADMIUM, AND CHROMIUM." DOI: UNKNOWN. AFFECTED SIDE: UNKNOWN.

  Patient problems: Breast Cancer; Hypersensitivity/Allergic reaction

  MAUDE report 13823469 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THE PATIENT'S SIGMA PRIMARY KNEE COMPONENTS WERE REMOVED AND REPLACED BY ATTUNE REVISION COMPONENTS. DOI: (B)(6) 2005; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 13167816 ↗
• InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DRAINING SORE CLOSE TO HER LEFT TOTAL KNEE INCISION : COMPLEX FLUID COLLECTION OR COMPLEX CYST WHICH AFTER SHE ABRADED IT SOME, WITH APPLICATIONS OF VOLTAREN GEL, HAS TUNED INTO AN ULCER OR SORE WHICH HAS NOT HEALED EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS THERE IS A REMOTE POSSIBILITY THE EVENT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2008. DATE OF REVISION: (B)(6) 2016 (INSERT, FOR INFECTION). DATE OF EVENT (ONSET): (B)(6) 2021. (LEFT KNEE). TREATMENT: SURGICAL IRRIGATION AND DEBRIDEMENT (NO PRODUCTS REVISED).

  Patient problems: Cyst(s); Pressure Sore/Ulcer

  MAUDE report 12437138 ↗
• MalfunctionJul 27, 2021Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE INNER STERILE PACKAGING COULD NOT BE LIFTED OUT OF THE OUTER STERILE PACKAGING AT THE TAB BECAUSE IT WAS STUCK. ANOTHER PRODUCT WAS AVAILABLE AND USED WITHOUT ISSUES. NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12233127 ↗
• InjuryMay 17, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION WAS RECEIVED INDICATED THAT THE PATIENT HAD REVISION DUE TO COMPLAINT OF PAIN.

  Patient problems: Insufficient Information; Pain

  MAUDE report 11837944 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Noise, Audible; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Patient Device Interaction Problem

  ON (B)(6) 2021, PATIENT PRESENTED FOR CLINICAL VISIT WITH PAINFUL LEFT KNEE, CATCHING OVER THE ANTERIOR ASPECT OF HER KNEE, DIAGNOSIS, PATELLAR CLUNK WITH ABUNDANT SCAR TISSUE AROUND PATELLAR BUTTON PER MRI. PLAN IS TO ADDRESS WITH AN ARTHROSCOPY, ON (B)(6) 2021, PRESENTING WITH PAIN, AND THE EQUIVALENT OF A PATELLAR CLUNK, STATUS POST LEFT TOTAL KNEE ARTHROPLASTY, WITH POST-OP DIAGNOSIS OF ABUNDANT SCAR OF THE SUPRAPATELLAR POUCH, UNDERSURFACE OF QUADRICEPS TENDON, AND IN THE PARAPATELLAR TENDON AREA, LEFT KNEE. PATIENT RECEIVED AN ARTHROSCOPIC RESECTION OF SCAR AT THE PERIPATELLAR AREA, UNDERSURFACE OF THE QUAD TENDON SUPRAPATELLAR POUCH, LEFT KNEE. THE PATELLAR BUTTON AND PROSTHESIS STILL APPEARED PRISTINE. THERE WERE NO COMPLICATIONS ASSOCIATED WITH THIS PROCEDURE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 11594439 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. OP NOTES FROM THE PRIMARY SURGERY AND THE REVISION ARE NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION OUTSIDE OF THIS FORM IS ALSO NOT AVAILABLE. SURGERON DID THE PRIMARY KNEE ON (B)(6) 2019 AT (B)(6). NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11121350 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - DEEP VEIN THROMBOSIS; ALSO HAD A RELATED GI BLEED. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY IT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020 (BILATERAL). DATE OF EVENT (ONSET): (B)(6) 2020. (RIGHT AND LEFT KNEES. THIS COMPLAINT CAPTURES THE LEFT KNEE). TREATMENT: SURGICAL PLACEMENT OF IVC FILTER IMPLANTATION, AS WELL AS CLIPPING OF THE GI BLEEDER (MEDICAL CONSULT FOR DIAGNOSIS AND TREATMENT).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available; Thrombosis

  MAUDE report 10443005 ↗
• MalfunctionFeb 12, 2020Device Damaged Prior to Use; Difficult to Open or Remove Packaging Material; Device Damaged Prior to Use; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE IMPLANT PACKAGE HAD BEEN COMPROMISED. THE CIRCULATING NURSE WAS UNABLE TO DROP THE IMPLANT AND WHEN THE SCRUB NURSE TRIED TO REMOVE THE IMPLANT FROM OUTER PACKAGE, THE PULL TAB BROKE. IT APPEARS THE OUTSIDE PACKAGE WAS DEFORMED AND DIDN'T ALLOW THE INNER PACKAGE TO BE REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9702246 ↗
• InjuryJul 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR TORN PATELLAR TENDON: EXTENSOR MECHANISM INSUFFICIENCY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DOI: (B)(6) 2019; DOE: (B)(6) 2019, (ONSET), (LEFT KNEE).

  Patient problems: Loss of Range of Motion; No Code Available; Tissue Damage

  MAUDE report 8771318 ↗
• InjuryApr 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR ISCHEMIC STROKE DUE TO PATENT FORAMEN OVALE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND PROBABLY RELATED TO PROCEDURE. DOI: (B)(6) 2019. DOE: (B)(6) 2019. TREATMENT INCLUDES LYTIC THERAPY. PLEASE NOTE, THIS PATIENT HAD BILATERAL PRIMARY KNEE REPLACEMENTS ON (B)(6) 2019. THIS PC CAPTURES THE LEFT KNEE IMPLANTS.

  Patient problems: Infarction, Cerebral

  MAUDE report 8546522 ↗
• InjuryMar 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS SUBSEQUENT PAIN AND POOR ROM.

  Patient problems: Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8416170 ↗
• InjuryAug 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL NOTIFICATION RECEIVED FOR PATELLAR TENDON RUPTURE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS RELATED TO DEVICE AND TO PROCEDURE. DOE: (B)(6) 2018; DOI: (B)(6) 2017; (LEFT KNEE). PATIENT HAD A PATELLAR TENDON REPAIR ON (B)(6) 2018, OPEN REPAIR, ON THE (B)(6) SHE AGAIN HAD AN OPEN REPAIR THIS TIME WITH A CERCLAGE WIRE AND EXTERNAL FIXATOR. THIS FIXATOR WAS REMOVED ON THE (B)(6).

  Patient problems: No Code Available

  MAUDE report 7788596 ↗
• InjuryAug 15, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  CLINICAL NOTIFICATION RECEIVED FOR REVISION RELATED TO LOOSENING OF TIBIAL AND FEMORAL COMPONENTS AND OSTEOLYSIS. DOI: (B)(6) 2000. DOR: (B)(6) 2018 . (LEFT KNEE).

  Patient problems: Not Applicable; Osteolysis; Pain

  MAUDE report 7784073 ↗
• InjuryJul 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL KNEE. PATIENT WAS BROUGHT TO SURGERY FOR REVISION. THE FEMORAL COMPONENT WAS REMOVED AND REPLACED WITH A POSTERIOR STABILIZED IMPLANT. DOI: (B)(6) 2013; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 7669548 ↗
• InjuryMar 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION DUE TO PATELLAR TENDON RUPTURE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7312944 ↗
• InjuryDec 7, 2017Loss of Osseointegration; Loss of Osseointegration

  SURGEON ASSISTANT SAID THAT PAIN/LOOSE FEMORAL COMPONENT WERE THE REASONS FOR REVISION.

  Patient problems: Pain

  MAUDE report 7098632 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, K943462, K952830. One submission often covers many models, so check the product and lot details in each record.

• Z-2949-2018 · Jul 18, 2018 · Terminated
  P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
• 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-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-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-0397-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 15.0mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0522.
• Z-0398-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 17.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0523.
• 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.
• Z-0399-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 30.0mm, 67mm M/L, 45 mm A/P, 30.0 mm, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0527.
• Z-0396-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 12.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0521.
• 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-0400-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 4, 20.0mm, 75mm M/L, 51mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0544.
• Z-0401-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 5, 12.5mm, 83mm M/L, 55mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0551.
• 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.

…and 1 more.