SIGMA 2024-56-111Recalls & reported problems
Depuy (Ireland) · SIGMA HP PARTIAL KNEE UNI FEMORAL SPACER · Class 1
All models of SIGMA (380)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295083313), received between Jan 16, 2018 and Aug 23, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 23, 2024Break; Break
IT WAS REPORTED THAT ITEMS HAVE PART OF THE PLASTIC SNAPPED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20047125 ↗MalfunctionDec 18, 2023Break; Break
THE FOLLOWING INSTRUMENT ISSUES WERE DISCOVERED DURING INSPECTION: PINNACLE GREATER HANDLES WERE WHITE SLEEVE DAMAGES PFC WHITE IMPACTORS WERE DEFORMED DUE TO USEAGE SP2 SIGMA FEM INSERT/EXTRACT HAD LOCKING MECH BROKEN SIGMA HP UNI FEMORAL SPACER HAD CHIPPED EDGE SIGMA HP UNI ANTERIOR CHISEL WERE BENT PFC SPEC1 PATELLAR CALIPER WERE THREAD STRIPPED THERE WERE NO PATIENT CONSEQUENCES OR SURGICAL DELAYS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18347255 ↗MalfunctionDec 18, 2023Break; Break
THE FOLLOWING INSTRUMENT ISSUES WERE DISCOVERED DURING INSPECTION: PINNACLE GREATER HANDLES WERE WHITE SLEEVE DAMAGES PFC WHITE IMPACTORS WERE DEFORMED DUE TO USEAGE SP2 SIGMA FEM INSERT/EXTRACT HAD LOCKING MECH BROKEN SIGMA HP UNI FEMORAL SPACER HAD CHIPPED EDGE SIGMA HP UNI ANTERIOR CHISEL WERE BENT PFC SPEC1 PATELLAR CALIPER WERE THREAD STRIPPED THERE WERE NO PATIENT CONSEQUENCES OR SURGICAL DELAYS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18346281 ↗MalfunctionSep 16, 2022Break; Break
THE ITEM WAS BROKEN DURING THE CLEANING PROCESS. NO FRAGMENTS WERE PRODUCED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15437758 ↗MalfunctionJan 16, 2018Break; Break
IT WAS REPORTED THAT THE FEMORAL SPACER BROKE IN THE MIDDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7193062 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
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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