P.F.C. SIGMA 96-1860Recalls & reported problems
Depuy (Ireland) · P.F.C. SIGMA DISTAL AUGMENTATION TRIAL SZ 3 4mm · Class 1
All models of P.F.C. SIGMA (487)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295240310), received between Feb 14, 2018 and Jan 5, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2022Break; Break
HUDSON ADAPTERS ARE STRIPPED. THE CONNECTION WITH THE REAMER WOULD SPIN WHEN MEETING RESISTANCE. REAMERS WERE DIFFICULT TO REMOVE AFTER USE. THIS OCCURRED WITH BOTH ADAPTERS AND WITH MULTIPLE SIZED REAMERS. NO DAMAGE TO THE REAMERS. THE TAB ON THE DISTAL AUGMENT TRIAL THAT ATTACHES THE TRIAL TO THE FEMORAL TRIAL BROKE OFF AS IT WAS REMOVED FROM THE TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13169288 ↗MalfunctionFeb 14, 2018Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE TRIAL POST WERE FRACTURED OFF WHILE TRIALING. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7269306 ↗
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