SIGMA 1024-54-307Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295002833), received between Feb 1, 2018 and May 9, 2024 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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.

• InjuryMay 9, 2024Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT THE POLY LINER DISASSOCIATED. NEW LINER BEING IMPLANTED. PATIENT ACL WAS DEFICIENT. THE POLY LINER SHOWED POSTERIOR WEAR. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19279061 ↗
• InjuryNov 9, 2021Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  THE POLY HAD WORN THROUGH. THE POLY IS AVAILABLE TO COLLECT FROM THE HOSPITAL HOWEVER IT IS CONTAMINATED AND WILL NOT BE DECONTAMINATED BY THE LOCAL STERILIZATION HUB. A POLY INSERT EXCHANGE WAS COMPLETED NO FURTHER ACTION FOR THE PATIENT.

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

  MAUDE report 12779024 ↗
• 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 11869796 ↗
• 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 11732283 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SEPTIC KNEE WASHOUT AND POLY EXCHANGE. RIGHT. ORIGINAL DOS WAS (B)(6) 2021. WASHOUT PERFORMED ON (B)(6) 2021.

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

  MAUDE report 11404494 ↗
• 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 9770095 ↗
• MalfunctionFeb 5, 2020Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE REP NOTICED A HOLE IN PACKAGE. BEING RETURNED DUE TO HOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9670669 ↗
• MalfunctionDec 27, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON CLEANED UNI METAL TRAY AND ATTEMPTED TO INSERT DEFINITIVE POLY NUMEROUS TIMES. THE SURGEON COULD NOT GET THE POLY TO ENGAGE THE TRAY. THE SURGEON SAID THE POLY LOCKING MECHANISM WAS DEFECTIVE. THEY OPENED THE SECOND POLY AND THE SURGEON EFFORTLESSLY IMPLANTED THE NEW POLY. DOE: (B)(6) 2019, RIGHT KNEE.

  Patient problems: Not Applicable

  MAUDE report 9525747 ↗
• 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 9224495 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS DISCOMFORT AND PAIN. THE SURGEON WASHED OUT THE KNEE WITH ANTIBIOTICS AND EXCHANGED THE POLY INSERT. DOI: (B)(6) 2017. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: Discomfort; No Code Available; Pain

  MAUDE report 8946993 ↗
• 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 8277821 ↗
• MalfunctionFeb 1, 2018Connection Problem; Connection Problem

  INTRAOPERATIVELY IT HAD NOT BEEN POSSIBLE TO FIX THE INLAY. IT DID NOT LOCK WITH THE TIBIAL PART. ANOTHER INLAY WAS AVAILABLE AND WAS INSERTED AND FIXED WITHOUT ANY ISSUES. SURGERY PROLONGATION 5 MINUTES. NO ADVERSE CONSEQUENCES FOR PATIENT OR USER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7233511 ↗