SIGMA 2024-11-407Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295082828), received between Jul 25, 2017 and Feb 6, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Break

  IT WAS REPORTED THAT DURING SURGERY THE SPACER FOR THE TRAILING OF THE FLEXION EXTENSION GAPS SNAPPED INTO TWO PIECES. ALL PIECES WERE RETRIEVED AND THERE WERE NO PATIENT CONSEQUENCES OR SURGICAL DELAYS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279056 ↗
• MalfunctionJun 20, 2025Break; Break

  IT WAS REPORTED THAT 4X7MM SIGMA UNI GAP BALANCER BROKE IN HALF DURING TRIALING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301506 ↗
• MalfunctionFeb 26, 2024Break; Break

  IT WAS REPORTED THAT THE TRIAL HAS SNAPPED IN TWO, IT IS ON TWO PARTS, THERE ARE NO PARTS LEFT IN THE PATIENT, THERE WAS NO AFFECT TO SURGERY OR TO PATIENT,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777043 ↗
• MalfunctionJan 25, 2024Break; Break

  IT WAS REPORTED THAT TIBIAL TRIAL BROKE DURING USE. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. DID THE EVENT HAPPEN DURING A PROCEDURE? YES. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? NO. EVENT OUTCOME/HOW WAS IT MANAGED? USED 1 SIZE UP FOR IMPLANTING. WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO COMPLAINT? NO WAS THE SURGERY PROLONGED DUE TO THE EVENT? IF YES, CONFIRM HOW MANY MINUTES DELAY: NO. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? NO. PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT. BROKEN AFTER TAKING IMPLANTING AND IT HAPPENS WHILE REMOVING IT FROM THE TIBIAL TRAY BEING IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18579521 ↗
• MalfunctionApr 27, 2023Break; Break

  IT WAS REPORTED THAT THE TRIAL SPACER BROKE DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16825114 ↗
• MalfunctionMar 17, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN. NO PATIENT HARM OR DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564384 ↗
• MalfunctionJan 10, 2023Break; Break

  IT WAS REPORTED THAT THE SPACER BLOCK WAS FOUND BROKEN AFTER SET WAS WASHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16133216 ↗
• MalfunctionJan 4, 2022Break; Break

  IT WAS REPORTED THAT THE INSERT TRIAL BROKE AT THE TIP UPON EXTRACTION. ALL PIECES REMOVED FROM PATIENT. NO FURTHER INFORMATION AVAILABLE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13151492 ↗
• MalfunctionAug 11, 2021Break; Break

  IT WAS REPORTED THAT AT THE VERY END OF THE CASE, THE TRIAL INSERT WAS BROKEN WHEN THE SURGEON WAS REMOVING THIS FROM THE KNEE (AFTER THE CEMENT HAD SET). ALL PIECES OF THE BROKEN ITEM WERE ACCOUNTED FOR. AT THIS POINT THE TRIAL INSERT WAS NOT REQUIRED FURTHER SO THERE IS NO ADVERSE IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12309448 ↗
• MalfunctionNov 24, 2020Break; Break

  SIGMA HP UNI TRIAL STICK SNAPPED WHILE REMOVING IT. NO DELAY IN CASE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10890239 ↗
• MalfunctionSep 25, 2020Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  NOTICED THE UNI TRIAL WAS WORN AND WAS NOT SLIDING IN PROPERLY ON THE TIBIAL TRAY. A NEW ONE HAS BEEN ORDERED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10589396 ↗
• MalfunctionJul 8, 2019Break; Break

  IT WAS REPORTED THAT THE SIZE 4X7 SHIN BROKE AT THE TIP UPON REMOVAL, ALL PIECES REMOVED FROM THE PATIENT. PLEASE SEND REPLACEMENT TO (B)(6). NO FURTHER INFO AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8767879 ↗
• MalfunctionFeb 14, 2019Break; Break

  IT REPORTED THAT THE INSERT TRIAL BROKE IN HALF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8340027 ↗
• MalfunctionDec 27, 2018Break; Break

  TRIAL INSERT SNAPPED DURING THE CEMENTING PROCESS. IT WAS ACCIDENTALLY HIT WITH A HAMMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8200188 ↗
• MalfunctionNov 16, 2018Break; Break

  IT WAS REPORTED THAT THE TIBIAL TRIAL SIZE 4 7MM BROKE IN TWO PIECES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8077334 ↗
• MalfunctionSep 12, 2018Break; Break

  IT WAS REPORTED THAT THE 3 SIGMA HP UNI TIB TRL WERE BROKEN DURING CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7868118 ↗
• MalfunctionJan 30, 2018Break; Break

  IT WAS REPORTED THAT THE TIBIAL TRIAL BROKEN INTO 2 PIECES. NO SURGICAL DELAY. NO PIECES OF BROKEN INSTRUMENTATION LEFT IN PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7227169 ↗
• MalfunctionJul 25, 2017Break; Break

  IT WAS REPORTED THAT THE SPACER WAS BROKEN.

  Patient problems: No Information

  MAUDE report 6739681 ↗