SIGMA 94-0022Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295223467), received between Aug 16, 2017 and Sep 14, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A RIGHT SIGMA TOTAL KNEE, DONE ¿SOMETIME IN 2012¿ PER SURGEON. PT WAS REVISED FOR PAIN, COMPONENTS WERE WELL FIXED, SURGEON CONVERTED TO POSTERIOR STABILIZED FEMUR COMPONENT. THE TIBIA COMPONENT WAS RETAINED AND NOT REMOVED. DOI: 2012, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12471049 ↗
• InjuryMay 20, 2020Loss of Osseointegration; Loss of Osseointegration

  REVISION TOTAL KNEE REPLACEMENT: THE PATIENT PRESENTED TO THE SURGEON WITH A PAINFUL KNEE. BONE SCAN SHOWED THE FEMUR AND PATELLA WERE LOOSE. INFECTION MARKERS ALL WITHIN NORMAL RANGE. WHEN IMPLANTS WERE REMOVED THERE WERE SIGNS OF OSTEOLYSIS BEHIND THE FEMORAL COMPONENT CENTRAL TO THE ANTERIOR CHAMFER REGION. NO OBVIOUS SIGNS OF OSTEOLYSIS ON THE POLY OF THE INSERT OR PATELLA. PHOTOS TAKEN OF IMPLANTS. IMPLANTS DISCARDED. NO AE REPORTED. NO DELAY IN THE SURGERY.

  Patient problems: Inadequate Osseointegration; No Code Available; Osteolysis; Pain

  MAUDE report 10075192 ↗
• InjuryAug 16, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS A FAILURE OF THE INSERT, DUE TO "CLUNK" NOISE COMING FROM THE KNEE. UPDATE 5-1-2017: MEDICAL RECORDS HAVE BEEN REVIEWED. PRIMARY OPERATIVE NOTE (B)(6) 2010 INDICATES THE PATIENT RECEIVED A RIGHT PFC TOTAL KNEE REPLACEMENT. NO COMPLICATIONS NOTED BY THE SURGEON. CLINICAL NOTES (B)(6) 2017 INDICATE THE PATIENT WAS BEING SEEN FOR INSTABILITY, PAIN, SWELLING AND CLUNKING OF THE RIGHT TOTAL KNEE REPLACEMENT. IT CAN BE GATHERED THAT THE REPORTED "CLUNK" IS MORE OF A SENSATION THAN A NOISE. REVISION OPERATIVE NOTES (B)(6) 2017 INDICATE DURING THE SURGERY THE SURGEON NOTED SEVERE POSTERIOR POLYETHYLENE WEAR, NO EVIDENCE OF INFECTION, COMPONENTS WERE WELL FIXED. THERE WAS ALSO NATURAL PATELLA BAJA WITH CHONDRAL DAMAGE. THE REVISION WAS COMPLETED WITHOUT ANY COMPLICATION NOTED BY THE SURGEON. REPORTABILITY HAS BEEN UPDATED. UPDATED 8-16-2017.

  Patient problems: Joint Swelling; No Code Available; Pain

  MAUDE report 6797710 ↗