NA 1294-35-115Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295025931), received between Jan 11, 2019 and Apr 24, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2024Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  J-C HEALTH CARE LTD. RECEIVED ON 9 APRIL 2024 A DEMAND LETTER DATED 28 MARCH 2024 PERTAINING TO A TOTAL KNEE REPLACEMENT WITH SIGMA IMPLANT. ACCORDING TO THE DEMAND LETTER, BACK IN 2019 PATIENT UNDERWENT A LT TKR IN RUSSIA (UNKNOWN IMPLANT) AND SUFFERED FROM INFECTION. THEREAFTER PATENT UNDERWENT SEVERAL INFECTION REVISIONS (ALSO IN RUSSIA) INCLUDING REMOVAL OF TIBIAL IMPLANT AND INSERTION OF SPACER, THAT DID NOT SOLVE THE INFECTION. DURING FEBRUARY-JULY 2020 PATIENT WAS TREATED AT SHEBA MEDICAL CENTER IN ISRAEL. ON (B)(6) 2020 (B)(4) CAPTURED FOR THE 1ST REVISION) PATIENT UNDERWENT A FIRST STAGE OF LT TKR REVISION AT SHEBA MEDICAL CENTER DUE TO "INFECTION AND INFLAMMATORY REACTION DUE TO INTERNAL JOINT PROSTHESIS (LEFT)" DURING WHICH HER IMPLANTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS IMPLANTED. THEREAFTER PATIENT WAS PLACED IN PLASTER CAST/BRACE AND KNEE FIXATION AND RECEIVED A LONG TERM SYSTEMIC ANTIBIOTIC TREATMENT UNDER LABORATORY MONITORING. AFTER 6 WEEKS OF ANTIBIOTIC TREATMENT WITH VANCOMYCIN AND LABORATORY MONITORING FOR ADDITIONAL 2 MONTHS, IT WAS FOUND THAT THERE WAS NO INFLAMMATION OF THE INFECTION FOLLOWING CESSATION OF THE ANTIBIOTICS AND THE KNEE WAS "QUIET", THE

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Loss of Range of Motion; Physical Asymmetry

  MAUDE report 19173474 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED A BROKEN TIBIA AND NEEDED TO BE REVISED. DOI: (B)(6) 2014; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 14684260 ↗
• InjuryFeb 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AT THE END OF STEM AND IN THE TIBIA. REMOVED POLY TRAY AND STEM. IMPLANTED SHORT CEMENTED STEM, NEW TRAY AND POLY. DOI: (B)(6) 2018, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11311488 ↗
• InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS REVIEWED. THE SURGEON NOTED THAT THE PATIENT EXPERIENCED EXPECTED ACUTE BLOOD LOSS ANEMIA POST-OPERATIVELY AND RECEIVED TWO UNITS OF PACKED RED BLOOD CELLS TO ADDRESS THE ISSUE. DOI: (B)(6) 2006; DOR #1: (B)(6) 2010; DOR #2: (B)(6) 2019; (RIGHT KNEE).

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9610786 ↗
• InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMMUNICATION RECEIVED. AS VERBALIZED,"I HAVE A DEPUY TC KNEE REVISION SYSTEM- PFC SIGMA KNEE REPLACEMENT. I HAVE LIMITED RANGE OF MOTION, THE PAIN GOES DOWN TO THE FEMUR PART OF THE LEG DOWN TO MY ANKLE. I'M HAVING PROBLEMS OF THIS APART FROM BEING NOT STABLE". UPDATE 23-MAY-2018: PATIENT CONFIRMED THE ABOVE SYMPTOMS OF PAIN, SWELLING, AND DECREASED ROM. MEDICAL RECORDS REPORT PAIN, AND INDICATE THAT PATIENT HAS HAD A KNEE REVISION ON AN UNKNOWN DATE. DOI: (B)(6) 2013; DOR: UNKNOWN; (LEFT KNEE).

  Patient problems: Fatigue; Loss of Range of Motion; Nerve Damage; No Code Available; Pain; Physical Asymmetry; Swelling; Swelling/ Edema; Weakness

  MAUDE report 8239277 ↗