P.F.C. SIGMA 96-1230Recalls & reported problems
Depuy (Ireland) · P.F.C. SIGMA POSTERIOR-LIPPED TIBIAL INSERT TRIAL SZ 2.5 8mm 67mm M/L 45mm 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
- 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 10603295236054), received between Aug 15, 2018 and Jun 23, 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
- Material Disintegration1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2022Break; Break
IT WAS REPORTED THAT THE DEVICE IS BROKEN, NO PATIENT IMPACT BUT DELAY TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14789334 ↗MalfunctionAug 15, 2018Break; Material Disintegration; Break; Material Disintegration
PLEASE COULD YOU KINDLY ADDRESS THE BELOW COMPLAINT AS A MATTER OF URGENCY, PLEASE. ACCORDING TO MY LOGGED COMPLAINTS, THIS IS WILL BE THE 5TH TIME THAT I AM LOGGING THE SAME COMPLAINT. PREVIOUS COMPLIANT REF NO.:(B)(4). FROM THE BELOW EMAIL, THE CLIENT HAS SINCE CALLED ME EXPLAINING THE ISSUE AGAIN. WHILST OPERATING TODAY, THE CONSULTANT NOTICED SEVERAL PIECES OF PLASTIC FROM THE TRIAL INSERT. OPERATION WAS DELAYED DUE TO THIS. CONSULTANT HAS SINCE REFUSED TO USE OUR PRODUCT UNTIL AN ALTERNATIVE IS ESTABLISHED. FROM THE INFORMATION I¿VE RECEIVED, THIS WAS ACTUALLY ONE OF THE NEW TRIAL INSERTS. THE TRUST HAS SINCE LOGGED A DATEX, REGARDING THIS. THE TRIAL HAS SINCE GONE FOR DECONTAMINATION, WHICH WILL BE READY ON (B)(6). EMAIL FROM HOSPITAL: THIS MORNING DURING A TOTAL KNEE REPLACEMENT WITH MR (B)(6) IT WAS NOTICED THAT SEVERAL VERY SMALL PIECES OF PLASTIC FROM THE TIBIAL INSERT TRIALS HAD COME OFF AND WERE IN THE WOUND AND ON THE FEMORAL TRIAL. I KNOW THESE HAVE BEEN REPLACED RECENTLY SO I AM NOT SURE WHY THIS CONTINUES TO OCCUR. MR (B)(6) HAS STATED THAT HE WILL NO LONGER USE PFC UNLESS THE ISSUE IS RESOLVED. WE HAVE SEVERAL TOTAL KNEE REPLACEMENTS NEXT WEEK SO IT IS CRUCIAL THAT
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7784212 ↗
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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