SIGMA 1024-52-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295002390), received between Jan 25, 2019 and Aug 11, 2025 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (4 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE INLAY WAS NOT ACCEPTED BY THE PARTIAL TIBIA. THERE WAS A SURGICAL DELAY OF SEVENTY (70) MINUTES. CHANGED TO ATTUNE. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22774135 ↗
• InjuryJul 24, 2025Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNICOMPARTMENTAL KNEE REPLACEMENT SURGERY FOR RIGHT KNEE OSTEOARTHRITIS WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY ON (B)(6) 2025, THE TIBIAL TRAY SUBSIDENCE WAS CONFIRMED. THE REVISION SURGERY VIA TOTAL KNEE REPLACEMENT WAS SCHEDULED ON (B)(6) 2025. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22589305 ↗
• MalfunctionMay 13, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE POLYS WOULD NOT SEAT INTO FINAL IMPLANT. THERE WAS A DELAY OF APPROXIMATELY TEN MINUTES. COULD NOT VERIFY THE POLYETHYLENE WAS SEATED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22009722 ↗
• MalfunctionMay 12, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE POLY IMPLANT WOULD NOT FULLY SEAT WHEN IMPLANTED DURING UKA PROCEDURE. THEY TRIED A DIFFERENT IMPLANT AND IT WOULDN'T SEAT. THEY CLEARED OUT ADDITIONAL BONE AND TRIED AGAIN BUT IT STILL WOULDN'T SEAT. THEY TRIED AN IMPLANT THE NEXT SIZE UP BUT IT WOULDN'T SIT EITHER. THE DOCTOR DECIDED THAT THE BEST CLINICAL OUTCOME WOULD BE TO PUT THE SMALLER IMPLANT IN AND USE THE PATIENTS WEIGHT TO FULLY SEAT THE IMPLANT. THE FEMORAL AND TIBIAL COMPONENTS WERE IMPLANTED WITHOUT PROBLEM. THE ROBOT APPEARED TO PERFORM AS EXPECTED. THE CASE HAD ISSUES WITH SEATING THE POLY IMPLANT AFTER THE ROBOTIC STEPS WERE COMPLETED. ALL UNI IMPLANTS ARE CEMENTED AS PLANNED. THERE WAS A 40 MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004275 ↗
• InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF 15 YEAR OLD SIGMA PARTIAL COMPLETED DUE TO PAIN AND STIFFNESS. THE INLAY LOOKS FINE. SMALL SCRATCHES WERE FOUND ON THE SURFACE. FEMUR AND TIBIA VERY STABLE AND PERFECTLY INTEGRATED.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 15749130 ↗
• InjuryJan 25, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  LOOSENING PARTIAL KNEE. PAIN. DOI: (B)(6) 2018, DOR: (B)(6) 2022, UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 13343188 ↗
• InjuryDec 20, 2021Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO TREAT SUDDEN SHARP PAIN AND GIVING WAY OF THE KNEE SECONDARY TO INSERT DISASSOCIATION. DOI: (B)(6) 2012; DOR: (B)(6) 2021 UNK KNEE.

  Patient problems: Fatigue; Loss of Range of Motion; Pain

  MAUDE report 13042784 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE PAIN. SURGEON CONVERTED TO TOTAL KNEE. DOI: (B)(6) 2017; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11869797 ↗
• MalfunctionApr 27, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A ROUTINE SIGMA UNI KNEE, IT WAS DISCOVERED THAT THE POLY INSERT WOULD NOT SEAT APPROPRIATELY INTO THE METAL TIBIAL TRAY AND LOOSENING OF THE POLY INSERT FROM METAL TIBIAL TRAY. SURGEON NOTICED IT DIDN'T "SIT" LIKE NORMAL AND COULD EASILY ELEVATE IT OUT OF THE TRAY. OPENED ANOTHER AND IT WAS BETTER, BUT NOT PERFECT CAUSING HIM TO THINK THAT MAYBE THERE WAS SOMETHING WRONG WITH THE METAL TRAY. AT THIS POINT SURGEON DECIDED IT WAS GOOD ENOUGH AND DIDN¿T WANT TO MAKE THINGS WORSE BY EXPLANTING THE ENTIRE CONSTRUCT. 5 MINUTES SURGICAL DELAY. NO FURTHER PATIENT INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 11732281 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN WITH A UNICONDYLAR PARTIAL KNEE IMPLANT CONVERTED TO A TOTAL KNEE. DOI: (B)(6) 2019. DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9770093 ↗
• InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS TORE PCL. THE DOCTOR REPLACED UNI WITH A POSTERIOR CRUCIAL TOTAL KNEE. DOI (B)(6) 2018; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9224494 ↗
• InjuryJan 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8277808 ↗