P.F.C. SIGMA 96-1452Recalls & reported problems
Depuy (Ireland) · P.F.C. SIGMA STABILIZED TIBIAL INSERT TRIAL SZ 4 12.5mm 76mm M/L 51mm A/P · Class 1
All models of P.F.C. SIGMA (487)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295238690), received between Dec 8, 2017 and Feb 6, 2023 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Crack2
Patient problems
- No Consequences Or Impact To Patient5
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2023Crack; Crack
IT WAS REPORTED THAT THE INSERT TRIALS CRACKED. ALL PIECES RETRIEVED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16302915 ↗MalfunctionOct 14, 2019Break; Break
BROKEN IMPACTOR TIP. BROKEN INSERT TRIAL. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? YES. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? YES. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9188274 ↗MalfunctionDec 3, 2018Crack; Crack
IT WAS REPORTED THAT THE 4X12.5MM CURVED INSERT TRIAL BROKE AROUND THE RIM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8125266 ↗MalfunctionSep 27, 2018Break; Break
IT WAS REPORTED THAT WHEN REMOVING THE TRIAL AFTER TRIALING, THE BOTTOM OF THE TRIAL BROKE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7914717 ↗MalfunctionMar 5, 2018Break; Break
IT WAS REPORTED THAT 4X12.5 MM STB INSERT TRIAL BROKEN, WHEN TAKING IT OUT. ALL PIECES RETRIEVED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7312703 ↗MalfunctionDec 8, 2017Break; Break
DER STATES THAT BOTH TIBIAL IMPACTOR AND SIZE 4X12.5 MM STB BROKE DURING SURGERY. TIBIAL IMPACTOR BROKE DURING IMPLANTATION AND 12.5 MM INSERT TRIAL BROKE WHILE REMOVING INSERT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7099588 ↗
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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