SIGMA 94-0013Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295223399), received between Feb 25, 2019 and Sep 16, 2024 — classified as 17 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (1 report).

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENTS RECEIVED FOR SPIN OUT. DEVICE AND PROCEDURE(RELATEDNESS). DEVICE RELATED: NOT RELATED. PROCEDURE RELATED: NOT RELATED. DATE OF EVENT: 13/AUG/2024. DEVICE LOCATION: LEFT . ADDITIONAL EVENT INFORMATION: ON (B)(6) 2024 MEDICAL RECORDS NOTE THE PATIENT HAS A HISTORY OF KNEE PAIN IN THE PATELLOFEMORAL LIGAMENT MEDIAL TO THE PATELLA. A SMALL BAND OF SCAR TISSUE IS PALPABLE. RADIOGRAPHS NOTE A WELL -PLACED ROTATING PLATFORM KNEE. THE SURGEON IMPRESSION IS OF A FIBROUS BAND OF TISSUE THAT IS BOTHERING THE PATIENT. THE SURGEON INJECTED THE KNEE WITH DEXAMETHASONE AND LIDOCAINE TO ADDRESS PAIN.

  Patient problems: Adhesion(s); Fibrosis; Pain

  MAUDE report 20232636 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR PULMONARY EMBOLISMS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: ORAL MEDICATION AND CLOT REMOVALS.

  Patient problems: Pulmonary Embolism

  MAUDE report 19468607 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 19343310 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR FOOT DROP. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE) TREATMENT: PATIENT FITTED WITH AFO.

  Patient problems: Nerve Damage

  MAUDE report 18703516 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A POLY EXCHANGE IN (B)(6) OF LAST YEAR. UNFORTUNATELY, SHE HAS PROGRESSED TO A CONFIRMED INFECTION. ALL PARTS AND PIECES WERE REMOVED AND A CEMENT SPACER WAS IMPLANTED. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17050045 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT PATIENT UNDERWENT A POLY EXCHANGE IN SEPTEMBER OF LAST YEAR. UNFORTUNATELY, PATIENT HAS PROGRESSED TO A CONFIRMED INFECTION. ALL PARTS AND PIECES WERE REMOVED AND A CEMENT SPACER WAS IMPLANTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 17049778 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RECURRENCE OF INFECTION WITH MRSA. 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: (B)(6) 2023 (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, PATELLAR, TIBIAL BASE, AND INSERT WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 17001595 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AND NEEDED TO BE CONVERTED TO A HINGE. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE : LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16137333 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFLAMMATORY RESPONSE, POSSIBLE INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2022; DATE OF EVENT: (B)(6) 2022 (LEFT KNEE). TREATMENT: ASPIRATION OF 30CC OF SEROSANGUINEOUS FLUID SENT FOR AEROBIC AND ANAEROBIC CULTURES, SYNOVIAL FLUID ANALYSIS.

  Patient problems: Erythema; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 14212370 ↗
• InjuryMar 30, 2022Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED DUE TO LOOSENING OF THE FEMUR AND TIBIA. PATIENT WAS NOT COMPLAINING OF PAIN, BUT X-RAY WERE TAKEN DUE TO LACK OF FOLLOW UP AFTER PROCEDURE. X-RAY REVEALED MAL ALIGNMENT. FEMUR WAS PRESSFIT AND HAD A FIBROUS UNION BETWEEN THE COMPONENT AND THE BONE. TIBIA DID NOT COME OUT WITH CEMENT ON THE COMPONENT. PATELLA WAS WELL FIXED. DOI: (B)(6) 2009, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT BONE CEMENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13950419 ↗
• InjuryAug 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR IT BAND CROSSOVER SYNDROME - IT BAND TENDINITIS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2021, (LEFT KNEE).

  Patient problems: Loss of Range of Motion; Muscle/Tendon Damage; Muscular Rigidity; Pain; Synovitis

  MAUDE report 12341492 ↗
• InjuryFeb 16, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ANTERIOR SCAR DEVELOPMENT, PATELLAR GRINDING, PAIN. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2021, DATE OF INTERVENTION: (B)(6) 2021, (LEFT KNEE). TREATMENT: ARTHROSCOPIC DEBRIDEMENT OF ADHESIONS.

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

  MAUDE report 11334505 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO FALL AT HOME 7 WEEKS POST OPERATIVE. THE KNEE BECAME UNSTABLE. THE FEMORAL AND THE TIBIAL COMPONENTS WERE REVISED TO A TC3/ MBT REVISION TRAY. CEMENT MANUFACTURER IS UNKNOWN. NO LOOSENING NOTED. DOI: (B)(6) 2020. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: Fall; No Code Available

  MAUDE report 10788121 ↗
• InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR MULTIPLE PULMONARY EMBOLI. 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) 2019. DATE OF EVENT (ONSET): (B)(6) 2020. (LEFT KNEE).

  Patient problems: Edema; No Code Available; Pulmonary Embolism

  MAUDE report 9864961 ↗
• InjuryNov 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, PRIMARY OPERATIVE NOTES (B)(6) 2019 INDICATE THE PATIENT RECEIVED BILATERAL TOTAL KNEE REPLACEMENTS DUE TO END STAGE OSTEOARTHRITIS. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. OFFICE NOTES (B)(6) 2019 INDICATE THE PATIENT EXPERIENCED WOUND DEHISCENCE WITH PURULENT BLOODY DRAINAGE OF THE LEFT KNEE. NO COMMENTS WERE MADE REGARDING THE RIGHT KNEE. PROCEDURE NOTES (B)(6) 2019 INDICATE THE PATIENT RECEIVED AN IRRIGATION AND DEBRIDEMENT DUE TO SUPERFICIAL WOUND INFECTION, SUPERFICIAL ABSCESS. UPON EXCISING THE WOUND, PUS AND NECROTIC SUBCUTANEOUS TISSUE WAS ENCOUNTERED. THE WOUND WAS CLEANSED COPIOUSLY WITH AN ANTIBIOTIC SOLUTION AND CLOSED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. OFFICE NOTES (B)(6) 2019 INDICATE THE PATIENT¿S WOUND IS WELL HEALED. SUTURES ARE INTACT. THERE IS NO SURROUNDING CELLULITIS OR ERYTHEMA. THE KNEE FLEXES TO 108 DEGREES EASILY. OFFICE NOTES (B)(6) 2019 INDICATE THE PATIENT IS DOING WELL BILATERALLY. RADIOGRAPHS REVEAL 2 WELL-PLACED TOTAL KNEE ARTHROPLASTIES.

  Patient problems: Abscess; Necrosis; Unspecified Infection; Wound Dehiscence

  MAUDE report 9280941 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RECENTLY FELL. PAINFUL KNEE WAS REVISED TODAY TO A LEFT 3 PS FEMUR AND STABILIZED RP 20 MM POLY FOR STABILITY.

  Patient problems: No Code Available; Pain

  MAUDE report 8500005 ↗
• InjuryFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WENT TO THE DOCTOR DUE TO TIBIAL PAIN. THE SURGEON CONVERTED TO A TC3 FEM AND REVISION MBT TIBIA. HE KEPT THE ORIGINAL PATELLA IMPLANTED. DOI: (B)(6) 2017; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8366616 ↗