P.F.C. 86-6502Recalls & reported problems
Depuy (Ireland) · P.F.C. TIBIAL CEMENTED STEM TRIAL 13mm x 60mm 2/3/3N · Class 1
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 10603295217220), received between Jul 16, 2020 and Oct 19, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Entrapment of Device” (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
- Entrapment of Device2
- Break1
Patient problems
- No Code Available2
- Not Applicable1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 19, 2020Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT A STEM TRIAL GOT STUCK IN THE FEMUR. THE STEM EXTRACTOR WE SCREWED INTO IT BROKE OFF. NO FURTHER INFORMATION IS AVAILABLE. SURGICAL DELAY OF 10 MINUTES.
Patient problems: No Code Available
MAUDE report 10697122 ↗MalfunctionJul 16, 2020Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT SIGMA 13X60 CEMENTED STEM CAME OFF IN FEMUR WHILE REAMING FOR SLEEVE. IT LODGED IN FEMUR AND SURGEON COULD NOT GET IT OUT. IT WAS IMPLANTED IN PATIENT.
Patient problems: No Code Available; Not Applicable
MAUDE report 10284212 ↗
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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