P.F.C. 86-6877Recalls & reported problems
Depuy Orthopaedics, Inc. · P.F.C. TIBIAL FLUTED ROD TRIAL 16mm x 75mm · Class 1
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 10603295217596), received between Jul 31, 2017 and Jun 15, 2022 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- Appropriate Device Problem Term/Code Not Available1
- Entrapment of Device1
Patient problems
- No Consequences Or Impact To Patient2
- Not Applicable2
- No Clinical Signs, Symptoms or Conditions1
- No Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 15, 2022Break; Break
IT WAS REPORTED THAT THE TRIAL STEM PEG BROKE OFF. WE REMOVED ALL BROKEN PIECES. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14697293 ↗MalfunctionJul 15, 2019Break; Entrapment of Device; Break; Entrapment of Device
REVISION TRIAL STEM FROM THE MBT REVISION SYSTEM DISENGAGED DURING USE AND WAS LEFT BEHIND IN THE PATIENT. THIS WAS ONLY RECOGNIZED DURING POST OPERATIVE XRAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8788941 ↗MalfunctionMar 20, 2019Break; Break
IT WAS REPORTED THAT THE TIP OF THE STEM TRIAL BROKE OFF INSIDE WHILE REAMING THE FEMORAL SLEEVE. THE TIP WAS RETRIEVED.
Patient problems: Not Applicable
MAUDE report 8437710 ↗MalfunctionDec 27, 2018Break; Break
EXTRACTION SCREW FOUND BROKEN IN TRIAL. PATIENT CONSEQUENCE? NO. PATIENT CONSEQUENCE DESCRIPTION: NOT USED DURING THE CASE. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8199722 ↗MalfunctionNov 30, 2018Break; Break
IT WAS REPORTED THAT THE END OF A STEM TRIAL CAME APART.
Patient problems: Not Applicable
MAUDE report 8120117 ↗MalfunctionJul 31, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING A KNEE REVISION THE 16X75MM STEM TRIAL BROKE (SEPARATED).
Patient problems: No Information
MAUDE report 6754640 ↗
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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