SIGMA 9505-02-145Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE BALANCED FB FEMORAL POSITIONER · Class 1
All models of SIGMA (380)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295228462), received between Feb 21, 2025 and Feb 21, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (3 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
- Material Fragmentation3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE POSITIONING INSTRUMENT'S RUBBER O-RINGS AT THE SHIM CONNECTIONS ARE WORN AND CREATES LOOSE RUBBER DEBRIS DURING USE. THE IMPACTOR SLIPS OFF THE KEEL-PUNCHES DURING USE EVEN WHEN SET SCREWS ARE TIGHTENED. THE TRIAL HAS A CRACK IN THE CONNECTION TO TRIAL TRAYS, NO PLASTIC PART HAVE FALLEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21432933 ↗MalfunctionFeb 21, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE POSITIONING INSTRUMENT'S RUBBER O-RINGS AT THE SHIM CONNECTIONS ARE WORN AND CREATES LOOSE RUBBER DEBRIS DURING USE. THE IMPACTOR SLIPS OFF THE KEEL-PUNCHES DURING USE EVEN WHEN SET SCREWS ARE TIGHTENED. THE TRIAL HAS A CRACK IN THE CONNECTION TO TRIAL TRAYS, NO PLASTIC PART HAVE FALLEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21432926 ↗MalfunctionFeb 21, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE POSITIONING INSTRUMENT'S RUBBER O-RINGS AT THE SHIM CONNECTIONS ARE WORN AND CREATES LOOSE RUBBER DEBRIS DURING USE. THE IMPACTOR SLIPS OFF THE KEEL-PUNCHES DURING USE EVEN WHEN SET SCREWS ARE TIGHTENED. THE TRIAL HAS A CRACK IN THE CONNECTION TO TRIAL TRAYS, NO PLASTIC PART HAVE FALLEN OFF.
Patient problems: Insufficient Information
MAUDE report 21432818 ↗
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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