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SIGMA 96-0015Recalls & reported problems

Depuy (Ireland) · SIGMA FEMORAL CRUCIATE RETAINING CEMENTED 5 RIGHT · Class 2 · Implant

All models of SIGMA (380)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This DePuy Sigma knee implant is a cemented metal-and-plastic knee replacement that keeps the ligaments. The 36 reports mostly describe the femoral component coming loose from where it was cemented, along with pain, infection, swelling and joint looseness, with several patients needing revision surgery. There are 34 injuries and no deaths. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
36
Deaths reported
0
Injuries reported
34
Recalls naming it
0

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10603295232049), received between Aug 17, 2017 and Aug 19, 2025 — classified as 34 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (12 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 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem19
  • Loss of or Failure to Bond12
  • Device Dislodged or Dislocated1
  • Difficult to Open or Remove Packaging Material1
  • Fracture1
  • Insufficient Device Problem Information1
  • Loose or Intermittent Connection1
  • Noise, Audible1

Patient problems

  • No Code Available18
  • Pain13
  • Unspecified Infection8
  • Swelling/ Edema4
  • Insufficient Information3
  • Joint Laxity3
  • Synovitis3
  • Adhesion(s)2

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 19, 2025Loss of or Failure to Bond; Fracture; Loss of or Failure to Bond; Fracture

    IT WAS REPORTED THAT THE PATIENT WAS BROUGHT TO THE OR FOR REVISION OF A BROKEN FEMORAL COMPONENT. PRODUCT STATED TO BE LOOSE: FEMORAL COMPONENT. LOOSENING INTERFACE: CEMENT/IMPLANT. CEMENT MANUFACTURER: UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

    Patient problems: Insufficient Information

    MAUDE report 22840185 ↗
  • InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

    Patient problems: Unspecified Infection

    MAUDE report 21346135 ↗
  • 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: Unspecified Infection

    MAUDE report 19144901 ↗
  • InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTED KNEE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

    Patient problems: Unspecified Infection

    MAUDE report 17208974 ↗
  • InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    CLINICAL ADVERSE EVENT RECEIVED FOR SEVERE PAIN. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION: UNK. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: REVISION (REVISED COMPONENTS NOT SPECIFIED).

    Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema

    MAUDE report 16580987 ↗
  • InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT STATED THAT "I HAD BILATERAL KNEE REPLACEMENTS PERFORMED (B)(6) 2011 WITH SIGMA IMPLANTS. MY ORTHOPEDIC SURGEON IN BALTIMORE, MD SAID THE KNEES WOULD LAST 15-20 YEARS. HAVING SIGNIFICANT PAIN IN BOTH KNEES WHILE CYCLING PROMPTED A VISIT TO DR. ON (B)(6) 2021 WHERE HE INFORMED ME THAT THE HARDWARE HAS COME LOOSE INDICATING A REVISION IS NEEDED. THIS IS WELL SHORT OF THE 15-20 YEARS LIFESPAN OF THE SURGERY. I HAD A CYCLING GOAL TO DO RAAM (RACE ACROSS AMERICA) AND HAD TO CANCEL A QUALIFIER IN LATE AUGUST IN UTAH. I WAS HOPING TO BECOME THE FIRST 70+ YEAR OLD RIDER TO BE AN OFFICIAL FINISHER. NOW DUE TO REVISION IN THE KNEES, I'LL HAVE TO WAIT AT LEAST 2 YEARS.

    Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain; Swelling/ Edema

    MAUDE report 16536356 ↗
  • 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. AFFECTED SIDE: RIGHT KNEE.

    Patient problems: Pain

    MAUDE report 16403429 ↗
  • InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    CLINICAL ADVERSE EVENT RECEIVED FOR POST OP MI. 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) 2022; (RIGHT AND LEFT KNEE). TREATMENT: ORAL MEDICATION (PLAVIX).

    Patient problems: Chest Pain; Myocardial Infarction

    MAUDE report 16183175 ↗
  • InjuryAug 30, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

    CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO ASEPTIC LOOSENING. DATE OF IMPLANT: (B)(6) 2009. DATE OF REVISION: (B)(6) 2022. (RIGHT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, INSERT, AND PATELLA REMOVED.

    Patient problems: Pain; Swelling/ Edema; Synovitis

    MAUDE report 15319503 ↗
  • InjuryDec 6, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

    THE PATIENT'S KNEE WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. NO DELAY IN SURGERY. DOI: (B)(6), 2017. DOR' (B)(6), 2021. RIGHT KNEE.

    Patient problems: Insufficient Information

    MAUDE report 12933375 ↗
  • InjuryOct 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISED A RIGHT KNEE FOR INSTABILITY. ORIGINAL SURGERY DONE IN 2006 BY DR. (B)(6) REG. MED. CTR. FULL KNEE REVISION TO ATTUNE REVISION. PATIENT IS A PLUMBER AND IS VERY ACTIVE. DOI: 2006, DOR: (B)(6) 2021, RIGHT KNEE.

    Patient problems: Joint Laxity

    MAUDE report 12655701 ↗
  • InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    SUBJECT ID: (B)(6). STUDY: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR FAILED TKA DUE TO POLYWEAR, OSTEOLYSIS, TIBIAL LOOSENING. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS RELATED TO DEVICE AND NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2002, DATE OF EVENT: (B)(6) 2021, DATE OF REVISION: (B)(6) 2021 (RIGHT KNEE). TREATMENT: REVISION OF ALL COMPONENTS.

    Patient problems: Adhesion(s); Joint Laxity; Swelling/ Edema; Synovitis

    MAUDE report 12539534 ↗
  • InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    STUDY: DOTS; CLINICAL ADVERSE EVENT RECEIVED FOR PULMONARY EMBOLISM; EVENT IS SERIOUS AND IS CONSIDERED SEVERE; EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021; DATE OF EVENT (ONSET): (B)(6) 2021; (RIGHT KNEE); TREATMENT: INJECTED MEDICATION (UNSPECIFIED).

    Patient problems: Pulmonary Embolism

    MAUDE report 11346891 ↗
  • InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT HAS INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2020; RIGHT KNEE.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 10960097 ↗
  • InjurySep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2017, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: ASPIRATED 90CC BLOOD, WILL SEND OFF TO RULE OUT INFECTION.

    Patient problems: Edema; Hematoma; Hemorrhage/Blood Loss/Bleeding; Limited Mobility Of The Implanted Joint; No Code Available; Pain

    MAUDE report 10537990 ↗
  • InjuryJul 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ADDITIONAL INFORMATION RECEIVED FOR MEDICAL RECORDS. PATIENT RECEIVED BILATERAL DEPUY HYBRID TKAS TO TREAT CHRONIC PAIN SECONDARY TO END-STAGE ARTHROSIS. THIS COMPLAINT WILL CAPTURE THE LEFT KNEE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE SURGEON NOTES THE LEFT KNEE HAD 1-MM LAXITY IN VARUS/VALGUS STRESSES IN FLEXION AND EXTENSION. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A SURGICAL I & D AND WOUND REPAIR TO TREAT PAIN AND WOUND DEHISCENCE SECONDARY TO A FALL. THERE WAS NO REPORTED PRODUCT PROBLEM WITH ANY IMPLANT AND THERE WERE NO REVISIONS PERFORMED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. *OF NOTE* THE PATIENT SUSTAINED AN IMPACTED TROCHANTERIC FRACTURE DURING THE FALL. IN CONSULTATION WITH AN SME, IT WAS DETERMINED TO NOTE THE TROCHANTERIC FRACTURE AS A NOTE ON THIS COMPLAINT. THERE WAS NO INFORMATION REGARDING TREATMENT OF THE FRACTURE. THEREFORE, IT WILL NOT BE CAPTURED WITHIN THIS COMPLAINT. DOI: (B)(6) 2020, DOE: (B)(6) 2020, LEFT KNEE.

    Patient problems: Fall; No Code Available; Pain; Wound Dehiscence

    MAUDE report 10262401 ↗
  • InjuryApr 14, 2020Noise, Audible; Patient Device Interaction Problem; Noise, Audible; Patient Device Interaction Problem

    PRIMARY OPERATIVE NOTES (B)(6) 2008 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. DEPUY SIGMA KNEE SYSTEM WAS UTILIZED, PATELLA WAS RESURFACED, CEMENT MANUFACTURER IS UNKNOWN. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. PRODUCT AND LOT INFORMATION IS NOT PROVIDED WITHIN THE MEDICAL RECORDS. OFFICE NOTES (B)(6) 2009 INDICATE THE PATIENT IS EXPERIENCING CONTINUED PAIN, MUSCULAR TIGHTNESS AND FEELINGS OF CATCHING AND CLICKING OF THE RIGHT KNEE. PHYSICAL THERAPY, ICE AND ORAL PAIN MEDICATION ARE NOTED AS TREATMENT. THERE IS NO INDICATION OF INVASIVE TREATMENT OR SURGICAL INTERVENTION RELATING TO THE RIGHT KNEE. IT IS INDICATED THE PATIENT ALSO HAD A LEFT KNEE ARTHROPLASTY PERFORMED IN (B)(6) 2004 FOLLOWED BY LEFT KNEE INFECTION AND SUBSEQUENT INSERT REVISION ON (B)(6) 2003. HOWEVER, THERE IS NO INFORMATION PROVIDED RELATING TO THE MANUFACTURER OF THE IMPLANTS. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF DEPUY PRODUCTS WERE INVOLVED WITH THE LEFT KNEE AT THIS TIME. PATIENT WAS REVISED TO ADDRESS CONTINUED PAIN. DOI: (B)(6) 2008. DOR: NOT REPORTED; (RIGHT KNEE).

    Patient problems: Muscular Rigidity; No Code Available; Pain

    MAUDE report 9957599 ↗
  • InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    (THIS PC CAPTURES THE SECOND REVISION OF (B)(4). PATIENT RECEIVED A RIGHT KNEE I & D AND INSERT REVISION TO TREAT WOUND BREAKDOWN, INFECTION, AND PATELLAR TENDON RUPTURE. THE SURGEON NOTES THAT THE PATIENT CONTINUED TO SOAK HIS KNEE IN A TUB, WHICH LED TO WOUND BREAKDOWN AND TENDON RUPTURE. THE PATIENT HAS NOT ADHERED TO HIS ANTIBIOTIC THERAPY PROTOCOL. INTRAOPERATIVELY, THE SURGEON DEBRIDED THE WOUND AND REPAIRED AS MUCH OF THE RUPTURED TENDON AS HE COULD. THE SURGEON NOTES THERE WAS A DEFECT IN THE PATELLA DUE TO BEING EXPOSED, BUT THE PATELLA WAS WELL-FIXED AND RETAINED. THERE WERE NO REPORTED PRODUCT PROBLEMS WITH THE REVISED TIBIAL INSERT OR THE RETAINED PATELLA, FEMORAL COMPONENT, OR TIBIAL TRAY. THE SURGEON WAS UNABLE TO FULLY CLOSE THE WOUND AND INSERTED A WOUND VAC. THE PATIENT WAS REVISED WITH DEPUY PRODUCTS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS AND THE PATIENT HAS BEEN REFERRED TO PLASTICS FOR RECONSTRUCTION OF THE SKIN. THE PATIENT WAS INSTRUCTED ON HOW TO MAINTAIN THE WOUND VAC, TO ABSTAIN FROM SOAKING THE KNEE IN THE TUB, AND TO CONTINUE STRICT ADHERENCE TO ANTIBIOTIC THERAPY. PATIENT WAS REFERRED TO A SKILLED NURSING FACILITY ON (B)(6) 2020. THE SURGEON

    Patient problems: No Code Available; Unspecified Infection; Wound Dehiscence

    MAUDE report 9922002 ↗
  • InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS POLYETHYLENE WEAR AND INSTABILITY. DATE OF IMPLANTATION: (B)(6) 1999. DATE OF REVISION: (B)(6) 2019; (RIGHT KNEE). TREATMENT: FEMUR, TIBIAL TRAY, AND TIBIAL INSERT WERE REVISED.

    Patient problems: No Code Available

    MAUDE report 9851312 ↗
  • 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 9849909 ↗
  • MalfunctionMar 5, 2020Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

    CUSTOMER IS REPORTING DIFFICULTIES WHILE REMOVING THE COVER OF STERILE IMPLANT PACKAGES. THESE ISSUES ARE NOT LIMITED TO A CERTAIN IMPLANT TYPE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9792753 ↗
  • InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    CLINICAL ADVERSE EVENT RECEIVED FOR ROTATING PLATFORM, SPIN OUT OF SPACER. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2020, (RIGHT KNEE). TREATMENT: RIGHT KNEE REVISION ON (B)(6) 2020, (FEMUR AND TIBIAL INSERT REVISED).

    Patient problems: No Code Available; Pain

    MAUDE report 9757827 ↗
  • InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2014; DATE OF EVENT: (B)(6) 2019; DATE OF REVISION: (B)(6) 2019; (RIGHT KNEE). TREATMENT: REVISION OF INSERT.

    Patient problems: Edema; No Code Available; Pain; Unspecified Infection

    MAUDE report 9728368 ↗
  • MalfunctionJan 21, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

    CLINICAL ADVERSE EVENT RECEIVED FOR ABNORMAL RADIOGRAPHIC EVALUATION - LUCENCIES. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2016, DATE OF EVENT: (B)(6) 2019, (RIGHT KNEE).

    Patient problems: Discomfort; No Code Available; Pain

    MAUDE report 9612164 ↗
  • InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENTS REVISED TO ADDRESS INFECTION OF THE KNEE. DOI: (B)(6) 2019. DOR: (B)(6) 2019; RIGHT KNEE.

    Patient problems: No Code Available; Unspecified Infection

    MAUDE report 9569579 ↗

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-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.
  • 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-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-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.

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

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