SIGMA 2011-03-051Recalls & reported problems
Depuy (Ireland) · SIGMA HP REVISION INSTRUMENTS FEMORAL ADAPTOR STEM BOLT TRIAL · 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 10603295081708), received between Jan 12, 2018 and Jan 12, 2022 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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 18, 2026.
Most reported problems
Device problems
- Device-Device Incompatibility2
- Material Twisted/Bent2
- Break1
- Difficult to Remove1
- Display Difficult to Read1
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 12, 2022Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS ARE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13235817 ↗MalfunctionJun 2, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THE SMALL NEUTRAL ADAPTER WOULD NOT SLIDE OVER THE REAMERS. IT IS KNICKED ON THE INSIDE. ALSO THE SMALL SCREW WOULD NOT LOCK INTO THE STEM PROPERLY FOR TRIALING. IT WAS CROSS THREADING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11922076 ↗MalfunctionSep 11, 2019Display Difficult to Read; Material Twisted/Bent; Display Difficult to Read; Material Twisted/Bent
IT WAS REPORTED THAT THE HEX HEAD OF THE BOLTS WERE STRIPPED AND NEEDS TO BE REPLACED. THE LOT NUMBERS COULD NOT BE READ. REPLACEMENTS TO BE SENT TO TRIDENT VIA FEDEX P1.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8998338 ↗MalfunctionMar 25, 2019Device-Device Incompatibility; Device-Device Incompatibility
THE STEM BOLT TRIAL WOULD NOT SMOOTHLY SCREW INTO FEMORAL TRIAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8450432 ↗MalfunctionJan 12, 2018Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation
IT WAS REPORTED THAT THE BOLT WAS STUCK INSIDE OF THE BOX AND STRIPPED OUT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7185269 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page