SIGMA 2024-11-307Recalls & reported problems
Depuy (Ireland) · SIGMA HP PARTIAL KNEE UNI TIBIAL TRIAL SZ 3 7mm · Class 1
All models of SIGMA (380)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Sigma partial knee tibial trial spacer block is a temporary sizing instrument used during knee replacement surgery. The 35 reports mostly describe the block or insert breaking, sometimes into two pieces, while the surgeon was positioning the final implant. In most cases the fragments were retrieved and the procedure finished, and no reports mention deaths or injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10603295082774), received between Sep 7, 2017 and Sep 22, 2026 — classified as 35 malfunctions.
The most frequently reported specific device problem is “Break” (35 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.
Reports received per month
Most reported problems
Device problems
- Break35
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Consequences Or Impact To Patient7
- No Information2
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Break
It was reported that Metal part broke away from the plastic handle, 3x7mm green spacer snapped in two during removal after trialing.Couple of breakages of instruments.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852981 ↗MalfunctionMar 17, 2026Break
IT WAS REPORTED THAT SIZE 3/7 MM INSERT WAS BROKEN IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24618622 ↗MalfunctionJan 15, 2026Break
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE OF THE KNEE IT WAS OBSERVED THAT THE DOG BONE TRIAL BROKE IN TWO PIECES. IT WAS REPORTED THAT NO PIECES WERE LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24087571 ↗MalfunctionMay 21, 2025Break; Break
IT WAS REPORTED THAT THERE WAS A BROKEN UNI TIBIAL INSERT TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22061678 ↗MalfunctionDec 3, 2024Break; Break
ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT : A. CAN YOU PLEASE PROVIDE THE LOT NUMBER OF THE IMPACTED PRODUCT? NO. C. DID THE INSTRUMENT BREAK INTO TWO OR MORE PIECES? 2 PIECES. D. WERE ALL PIECES RETRIEVED FROM THE PATIENT IF DEPUY SYNTHES INSTRUMENTATION BROKE DURING SURGERY? YES. E. WAS SURGERY TIME EXTENDED DUE TO A DEPUY SYNTHES PRODUCT? IF YES, HOW LONG? NO. F. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20838014 ↗MalfunctionAug 26, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT SNAPPED IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20071590 ↗MalfunctionMar 13, 2024Break; Break
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE INSTRUMENT BROKE INTO 2 PIECES ¿ NO FRAGMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18893401 ↗MalfunctionMar 7, 2024Break; Break
IT WAS REPORTED THAT A PIECE OF THE SPACER BROKE OFF WHEN THE IMPLANT WAS INSERTED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, ACTION TAKEN WHEN EVENT OCCURRED? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? NO, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN, (B)(4). DEVICE PROPERTY OF? NONE, DEVICE IN POSSESSION OF? NONE, BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.? TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18856063 ↗MalfunctionFeb 28, 2024Break; Break
ITEM HAS BROKEN INTO 2 PIECES. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18797213 ↗MalfunctionFeb 27, 2024Break; Break
A. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO, THIS WAS DURING THE FINAL IMPLANT STAGE THE TRIAL IS USED TO POSITION THE TIBIAL TRAY, IT SNAPPED DURING THE REMOVAL OF THE TRIAL BUT DID NOT AFFECT THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18788129 ↗MalfunctionJan 12, 2024Break; Break
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18502616 ↗MalfunctionJan 9, 2024Break; Material Deformation; Break; Material Deformation
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY BECAUSE OF THIS EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? B. WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? C. WHAT PART OF THE INSTRUMENT WAS BROKEN? D. DID IT BREAK INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY WHAT IS THE ALLEGED DEFICIENCY, IS IT DULL, BENT, CRACKED, STRIPPED, SCRATCHED, WORN, SCRATCHED, CROSS-THREADED, OR ANY DEVICE INTERACTION ISSUES? A) NO. B) NO. C) THE END OF THE INSTRUMENT. D) 2 PIECES. THE INSTRUMENT WAS BENT ACCIDENTALLY AND BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18475285 ↗MalfunctionNov 28, 2023Break; Break
TIBIAL TRIAL SNAPPED DURING SURGERY. ALL PIECES RETRIEVED. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18217921 ↗MalfunctionNov 13, 2023Break; Break
IT WAS REPORTED THAT WHILE TRIALING, THEY BROKE TRIAL SIZER. IT WAS UNKNOWN ABOUT SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18121685 ↗MalfunctionOct 20, 2023Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? YES, PATIENT STATUS/ OUTCOME / CONSEQUENCE: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. (B)(4). DEVICE PROPERTY OF : NONE. DEVICE IN POSSESSION OF : NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17979175 ↗MalfunctionOct 17, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENT BROKE INTO 2 PIECES. NO TIME ADDED ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17951231 ↗MalfunctionSep 27, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THE TRIAL TIBIAL INSERT SIDE OF THE SPACER SNAPPED INTO TWO PIECES AND ALL PIECES WERE RETRIEVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17825830 ↗MalfunctionAug 22, 2023Break; Break
IT WAS REPORTED THAT DEVICE IS BROKEN. THERE WAS NO DELAY TO SURGERY OR ADVERSE EFFECT ON PATIENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17596945 ↗MalfunctionJul 13, 2023Break; Break
IT WAS REPORTED THAT WHEN THE SURGEON HIT THE TIBIAL TRIAL IMPACTOR THE 'LOLLIPOP' SNAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17315716 ↗MalfunctionJun 26, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED. STATES, THAT THE SPOON SNAPPED INTO TWO PIECES IN THE MIDDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17199478 ↗MalfunctionJun 5, 2023Break; Break
DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, TWO TIBIAL TRIALS WERE BROKEN. THE HEAD ON ONE END HAD SNAPPED. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A SIGMA HP UNI TIB TRL SZ3 7MM. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17060886 ↗MalfunctionMay 19, 2023Break; Break
IT WAS REPORTED THAT THE INSERT TRIAL HANDLE BROKE WHILE REMOVING FROM PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16964782 ↗MalfunctionSep 21, 2022Break; Break
IT WAS REPORTED THE PLASTIC TRIAL SNAPPED DURING TRIALING. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15460956 ↗MalfunctionMay 26, 2022Break; Break
THE INSTRUMENTS DID NOT PERFORM AS INTENDED. THE SPACER BLOCK BROKE AT THE HANDLE AND ALL PIECES WERE RETRIEVED. THE FIXATION PIN COLD WELDED TO THE RM/LL TIBIAL RESECTION BLOCK. THE UNIVERSAL HANDLE WAS NOT CAPTURING SECURELY. SURGICAL DELAY OF 5 MINUTES OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14516667 ↗MalfunctionJan 24, 2022Break; Break
SHIMS BROKE DURING SURGERY. EACH OF THEM BROKE OFF AT THE HANDLE SIDE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13338648 ↗
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- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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