P.F.C. 87-5704Recalls & reported problems
Depuy Orthopaedics, Inc. · P.F.C. SIGMA POROCOAT TRAY SCREW - LOW PROFILE 6.5mm 35mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295218685), received between Feb 27, 2018 and Feb 27, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure To Adhere Or Bond” (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
- Failure To Adhere Or Bond2
Patient problems
- Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 27, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond
THE PATIENT WAS REVISED TO ADDRESS KNEE PAIN IN THE TOTAL KNEE. IT WAS STATED THAT, THERE WAS NO PATELLA IN THE PATIENT FROM THE FIRST SURGERY. BONE SCAN WAS HOT AROUND THE TIBIA. IT WAS DECIDED BY THE DOCTOR THAT THE TIBIA WAS LOOSE AT THE BONE TO IMPLANT INTERFACE. PRESSFIT SIGMA FB TIBIA WAS PULLED OUT AND A SIGMA FIXED BEARING CEMENTED TIBIA WITH A STEM REPLACED THE PRESSFIT ONE. THE PATELLA WAS RESURFACED AT THIS TIME AS WELL. DOI: (B)(6) 2016, DOR: (B)(6) 2018, RIGHT KNEE.
Patient problems: Pain
MAUDE report 7298840 ↗InjuryFeb 27, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond
THE PATIENT WAS REVISED TO ADDRESS KNEE PAIN IN THE TOTAL KNEE. IT WAS STATED THAT, THERE WAS NO PATELLA IN THE PATIENT FROM THE FIRST SURGERY. BONE SCAN WAS HOT AROUND THE TIBIA. IT WAS DECIDED BY THE DOCTOR THAT THE TIBIA WAS LOOSE AT THE BONE TO IMPLANT INTERFACE. PRESSFIT SIGMA FB TIBIA WAS PULLED OUT AND A SIGMA FIXED BEARING CEMENTED TIBIA WITH A STEM REPLACED THE PRESSFIT ONE. THE PATELLA WAS RESURFACED AT THIS TIME AS WELL. DOI: (B)(6) 2016. DOR: (B)(6) 2018. RIGHT KNEE.
Patient problems: Pain
MAUDE report 7298832 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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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