SIGMA 96-0018Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10603295232070), received between Sep 27, 2017 and Jul 7, 2025 — classified as 35 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryJul 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE IMPLANTS WERE REVISED (WITH THE EXCEPTION OF THE PATELLA) DUE TO SEVERE DISLOCATION OF THE KNEE JOINT. THEY WERE IMPLANTED IN (B)(6) 2014.

  Patient problems: Joint Dislocation

  MAUDE report 22415774 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED: ON (B)(6) 2024, MEDICAL RECORDS NOTED THE PATIENT IS 6 WEEKS POST HIP ARTHROPLASTY. IT WAS SAID THAT THE PATIENT HAD A CT SCAN TWO WEEKS AGO AND IT SHOWED A PULMONARY EMBOLISM. THE PATIENT WAS PRESCRIBED ELIQUIS MEDICATION AND OVERALL IS DOING WELL. ON (B)(6) 2024, THE PATIENT IS NOW 3 ½ MONTHS OUT FROM A RIGHT TOTAL HIP IT WAS NOTED THAT THE PATIENT HAD A PE AFTERWARDS. DEPUY STEM AND CUP ARE REPORTED TO BE WELL PLACED ON A RADIOGRAPH.

  Patient problems: Pulmonary Embolism

  MAUDE report 20280879 ↗
• 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 19144899 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO. B. WAS THE PATELLA REVISED? NO. THE PATELLAR COMPONENT WAS RETAINED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19135103 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PAIN AND ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021. DATE OF EVENT: 29 FEB 2024. (RIGHT KNEE). TREATMENT: REVISION; FEMORAL, TIBIAL, INSERT, AND PATELLA WERE REVISED.

  Patient problems: Adhesion(s); Pain

  MAUDE report 18874205 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: (B)(6) 2023. (RIGHT KNEE). TREATMENT: FEMORAL COMPONENT, TIBIAL BASE, INSERT, AND PATELLA WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 18073881 ↗
• InjuryJun 7, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED: A. WERE THERE ANY DEPUY INSTRUMENTATION THAT BROKE DURING SURGERY? IF YES, PLEASE PROVIDE THE DETAILS ON FUTURE REPORTS: IF THE PATIENT WAS NOT AFFECTED BY INSTRUMENTATION THAT WAS BROKEN INTO MORE THAN ONE PIECE PLEASE MARK THIS QUESTION N/A, NOT APPLICABLE. --> NO B. WAS THERE ANY ALLEGATION AGAINST THE TIBIAL INSERT? IF YES, PLEASE PROVIDE THE PRODUCT DETAILS. --> NO C. WAS THE PATIENT EXPERIENCING ANY ADVERSE SYMPTOMS THAT LED TO THE REVISION SURGERY? --> YES D. CAN YOU PLEASE CONFIRM THE CEMENT QUANTITY? --> 6 40G BOXES IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 17079490 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR WOUND DEHISCENCE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: 29 SEP 2022. (RIGHT KNEE). TREATMENT: WOUND VAC.

  Patient problems: Wound Dehiscence

  MAUDE report 16784896 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO KNEE BECAME INSTABILITY AND NEEDED TO BE REVISED TO A HINGE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15974048 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: (B)(6) 2020, DATE OF REVISION: (B)(6) 2022 (RIGHT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT AND INSERT WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Limb Fracture; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 15966176 ↗
• InjuryJul 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR DVT. 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 KNEE). TREATMENT: ORAL MEDICATION (ELIQUIS X FOR 6 MONTHS) AND MONITORING BY PRIMARY PHYSICIAN.

  Patient problems: Discomfort; Joint Contracture; Muscular Rigidity; Pain; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 14886246 ↗
• InjuryApr 5, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  CLINICAL ADVERSE EVENT RECEIVED FOR LOOSENING OF THE FEMORAL COMPONENT, POSSIBLE DEEP INFECTION - ULCER ON KNEE AS A RESULT OF CUPPING OF HER KNEE AND THIS IS DRAINING; LOOSENING OF THE FEMUR ON X-RAY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS PROBABLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2022. (RIGHT KNEE). TREATMENT: NONE, REVISION SURGERY PENDING.

  Patient problems: Abscess; Fluid Discharge; Pain; Unspecified Infection

  MAUDE report 14017505 ↗
• InjuryJan 18, 2022Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INCREASING PAIN AND SWELLING. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. DOI: (B)(6) 2012; DOE: UNK (RIGHT KNEE ASPIRATIONS); DOR: (B)(6) 2021; (RIGHT KNEE).

  Patient problems: Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 13282857 ↗
• InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, IT WAS REPORTED THAT THE PATIENT RECEIVED A RIGHT KNEE INSERT REVISION TO TREAT PAIN, STIFFNESS, SWELLING, AND MILD INSTABILITY. UPON ENTERING THE JOINT THE SURGEON EVACUATED JOINT EFFUSION AND TREATED EXTENSIVE SYNOVITIS WITH A COMPLETE SYNOVECTOMY. THE SURGEON NOTES THAT ALL COMPONENTS WERE WELL-FIXED WITH NO SIGN OF LOOSENING. A LARGE 7-8 MM OSTEOPHYTE WAS REMOVED FROM THE POSTERIOR FEMUR AND A SMALL BONE OVERGROWTH WAS REMOVED FROM THE PATELLA. THE SURGEON EXCISED SOME AREAS OF HYPERTROPHIC BONE FROM THE TIBIA. THE SURGEON NOTES THAT THE SYNOVITIS AND HYPERTROPHIC BONE WERE SECONDARY TO THE INFLAMMATION CAUSED BY THE IRRITATION CAUSED BY THE LARGE FEMORAL OSTEOPHYTE. THE FEMORAL COMPONENT, TIBIAL TRAY, AND PATELLA WERE RETAINED. THE TIBIAL TRAY WAS REVISED WITH DEPUY AOX CR INSERT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. REVIEW OF THE CLINICAL DATABASE CONFIRM THAT THE REVISION WAS PERFORMED ON THE RIGHT KNEE. DOI: (B)(6) 2021, DOE: UNK (RIGHT KNEE ASPIRATIONS), DOR: (B)(6) 2021 (INSERT EXCHANGE).

  Patient problems: Inflammation; Joint Laxity; Muscular Rigidity; Pain; Synovitis; Unspecified Musculoskeletal problem

  MAUDE report 13101992 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OPERATIVE NOTES ON (B)(6) 2021 INDICATED THAT THE PATIENT RECEIVED A RIGHT KNEE ACUTE PATELLAR TENDON RUPTURE REPAIR. THE PATIENT FELT A ¿POP¿ AND EXPERIENCED SIGNIFICANT PAIN AND INABILITY TO EXTEND HER RIGHT KNEE. EXAM REVEALED SWELLING AND WARMTH OF THE JOINT, RUPTURE OF THE PATELLA TENDON, PATELLA ALTA, AND FRACTURE OF THE INFERIOR POLE OF THE PATELLA BONE. UPON ENTERING THE KNEE, SIGNIFICANT HEMATOMA WAS ENCOUNTERED AND EVACUATED. THE REPAIR AND WOUND CLOSURE WERE COMPLETED WITHOUT INDICATION OF COMPLICATION ¿ NO IMPLANTS REVISED.

  Patient problems: Hematoma; Muscle/Tendon Damage

  MAUDE report 12583955 ↗
• InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS, END-STAGE, RIGHT KNEE. THE SURGEON REPORTED THAT THE PATIENT HAD A VERY TIGHT EXTENSOR MECHANISM THAT WHEN THE KNEE WAS INITIALLY FLEXED THERE WAS A ¿LITTLE BIT OF PEEL OF THE (PATELLA) TENDON¿. ANCHORS WERE PLACED AND SUTURES WERE USED TO ANCHOR THE TENDON IN REPAIR.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Muscle/Tendon Damage

  MAUDE report 12331611 ↗
• InjuryAug 4, 2021Adverse 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 THERE IS A REMOTE POSSIBILITY EVENT IS RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. ON (B)(6) 2021, THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS, END-STAGE, RIGHT KNEE. THE SURGEON REPORTED THAT THE PATIENT HAD A VERY TIGHT EXTENSOR MECHANISM THAT WHEN THE KNEE WAS INITIALLY FLEXED THERE WAS A ¿LITTLE BIT OF PEEL OF THE (PATELLA) TENDON¿. ANCHORS WERE PLACED AND SUTURES WERE USED TO ANCHOR THE TENDON IN REPAIR. (B)(6) 2021 NOTED THAT THE PATIENT¿S PATELLA TENDON HAD PEELED OFF QUITE SIGNIFICANTLY DURING THE SURGERY, WHICH IS WHY SHE IS ON RESTRICTED FLEXION. ON 12 JUL 2021, THE PATIENT HAD A MANIPULATION UNDER ANESTHESIA TO ADDRESS ARTHROFIBROSIS OF THE RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS STIFFNESS DATE OF IMPLANTATION: (B)(6) 2021 DATE OF EVENT (ONSET): (B)(6) 2021 (RIGHT KNEE). TREATMENT: KNEE MANIPULATION UNDER ANESTHESIA.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion; Muscular Rigidity

  MAUDE report 12277812 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RECURRENT DRAINAGE FROM INCISIONAL AREA: INFECTION. ON (B)(6) 2021, THE PATIENT PRESENTED FOR A CLINIC VISIT FOR AN EVALUATION DUE TO RIGHT KNEE DRAINAGE AND EDEMA. CULTURES REVEALED STAPHYLOCOCCUS EPIDERMIDIS AND CANDIDA. ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS WOUND DRAINAGE, RECURRENT INFECTION, AND EDEMA. THE POST-OPERATIVE DIAGNOSIS WAS INDICATED AS RECURRENT INFECTION WHILE THE "FINDINGS" SECTION OF INTRA-OP NOTE DESCRIBED THE INFECTION AS CHRONIC. THE SURGEON NOTED THERE WAS AN EROSION OF THE MIDDLE PORTION OF THE EXTENSOR MECHANISM JUST AT THE LEVEL OF THE JOINT LINE. IT IS INDICATED THE PATIENT PREVIOUSLY UNDERWENT AN EXTENSOR MECHANISM RECONSTRUCTION IN (B)(6) 2020 TO ADDRESS A RUPTURED EXTENSOR MECHANISM. CAPTURED ON (B)(4). THE SURGEON ALSO NOTED REMOVAL OF NECROTIC-APPEARING TISSUE. ALL COMPONENTS WERE REMOVED AND WERE REPLACED WITH A SURE SPACE FEMORAL SPACER AND SURE SPACE TIBIAL SPACER. TWO GRAMS OF VANCOMYCIN AND 100 MG OF AMPHOTERICIN WERE USED PER BATCH OF CEMENT. TWO BATCHES OF DEPUY 2 WITH GENTAMICIN CEMENT WAS UTILIZED. THE SURGEON INDICATED THE PATIENT WOULD BE ON IV ANTIBIOTICS POST-OPERATIVE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fluid Discharge; Necrosis; Swelling/ Edema

  MAUDE report 12121140 ↗
• InjuryJun 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION TO ADDRESS INFECTION. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF REVISION: (B)(6) 2021, (RIGHT KNEE). TREATMENT: REVISION, REMOVAL OF ALL IMPLANTS, WITH PLACEMENT OF AN ANTIBIOTIC SPACER.

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

  MAUDE report 12027395 ↗
• InjuryJun 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS CONFIRMED INFECTION. AN ANTIBIOTIC SPACER WAS PLACED. NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2021. RIGHT KNEE.

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

  MAUDE report 12026016 ↗
• InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PATELLAR TENDON RUPTURE: EXTENSOR MECHANISM INSUFFICIENCY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021; DATE OF EVENT (ONSET): (B)(6) 2021; (RIGHT KNEE). MEDICAL RECORDS WERE REVIEWED. THE PATIENT UNDERWENT BILATERAL KNEE REPLACEMENTS WITHOUT COMPLICATIONS ON (B)(6) 2021 UTILIZING DEPUY CEMENT. BILATERAL PATELLAS WERE RESURFACED AT THAT TIME. ON (B)(6) 2021, THE PATIENT WAS RISING FROM A LOW TOILET WHEN SHE FELT A POP AND IMMEDIATE PAIN IN THE RIGHT KNEE. WORKUP REVEALED PATELLA ALTA WITH A SMALL CHIP OF BONE OFF OF THE INFERIOR POLE OF THE PATELLA LEADING TO A DIAGNOSIS OF A COMPLETE PATELLA TENDON RUPTURE WITH AVULSION FRACTURE. UPON XRAY REVIEW, IT WAS ALSO NOTED THAT THERE WAS ANTERIOR TILT OF THE PATELLA BUT THIS WAS NOT NOTED WITHIN THE OPERATIVE NOTES OF THE PATELLA TENDON REPAIR. THE PATIENT WAS UNABLE TO LIFT HER LEG AT THE TIME. ON (B)(6) 2021, A RIGHT PATELLA TENDON REPAIR WAS COMPLETED. SURGEON NOTES EVIDENCE OF A HEMATOMA AND A SMALL AREA OF COMPROMISED SKIN WHERE IT LOOKED LIKE

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

  MAUDE report 11984288 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: DOTS ON (B)(6) 2021, THE PATIENT UNDERWENT A RIGHT KNEE REVISION TO ADDRESS TIBIAL INSERT POLYETHYLENE WEAR, PAIN, INSTABILITY, AND SYNOVITIS. THE TIBIAL INSERT WAS THE ONLY PRODUCT REVISED. THIS WAS CAPTURED IN (B)(4). THE SURGEON NOTED DURING PREPARATION OF THE KNEE FOR THE NEW COMPONENT THERE WAS A PARTIAL AVULSION OF THE PATELLA TENDON FROM THE KNEE TIBIAL TUBERCLE. THIS AREA WAS OVER SEWN WITH TWO SUTURES. DOI: (B)(6) 2001; DOE: (B)(6) 2021; (RIGHT KNEE).

  Patient problems: Muscle/Tendon Damage

  MAUDE report 11913574 ↗
• InjuryMay 11, 2021Loss 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

  ON (B)(6) 2021, THE PATIENT'S RIGHT KNEE WAS REVISED TO ADDRESS ASEPTIC LOOSENING OF THE FEMUR AND TIBIAL TRAY COMPONENTS, ALONG WITH ARTHROFIBROSIS. FEMUR, TIBIAL TRAY, AND TIBIAL INSERT COMPONENTS WERE REVISED, AND DEPUY ATTUNE REVISION COMPONENTS RE-IMPLANTED TO TREAT.

  Patient problems: Fibrosis; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 11804544 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. THE CR FEMUR AND POLY WERE REPLACED WITH A TC3 FEMUR ALONG WITH A PS RP 2.5 PS INSERT. THE SURGEON ADDED DISTAL AUGMENTS AND PRESSFIT STEM FOR ADDITIONAL STABILITY. THE LOT NUMBERS ON THE TWO IMPLANTS THAT WERE EXTRACTED WERE UNABLE TO BE IDENTIFIED. DOI: UNKNOWN. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11691213 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR ARTHROFIBROSIS : ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO BOTH DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2014, DATE OF EVENT (ONSET): (B)(6) 2015, (RIGHT KNEE). TREATMENT: SURGICAL INTERVENTION - CLOSED MANIPULATION OF THE KNEE UNDER ANESTHESIA.

  Patient problems: Adhesion(s)

  MAUDE report 11594388 ↗

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-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-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-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-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-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.
• 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-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-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-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-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.

…and 1 more.