PROFEMUR® PYRD0004Recalls & reported problems
Microport Orthopedics Inc. · PROFEMUR® RAZ STEM SZ 4 · Class 2 · Implant
All models of PROFEMUR (116)
Data updated Oct 16, 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 M684PYRD00041), received between Mar 3, 2020 and Nov 12, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Failure to Osseointegrate1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 12, 2020Failure to Osseointegrate; Failure to Osseointegrate
ALLEGEDLY, CUP APPEARS TO BE INCORRECTLY POSITIONED. HEAD WAS REMOVED ALONG WITH SHELL AND CAME OUT WITH THE NECK EXTRACTION DEVICE. APPEARS THAT THERE WAS A LITTLE INGROWTH ON THE CUP AND STEM. (RIGHT HIP). PHOTOS OF EXPLANTS AND X RAY ARE BEING SENT.
Patient problems: Insufficient Information
MAUDE report 10828992 ↗InjuryMar 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PAIN IN THE LATERAL PROXIMAL FEMUR, STEM CAME OUT WITH THE NECK AND HEAD. STRYKER STEM AND HEAD WENT IN AND NONE OF OUR IMPLANT WENT IT. ADDITIONAL INFORMATION ON 08/29/2019: COMPONENT NOT REVISED: METAL LINER 44MM DYNASTY PART NUMBER : DLCO-6644 LOT NUMBER: 010138421. COCR FEMORAL HEAD 28MM SLT TAPER +10.5MM NECK CONFIRMED AS REVISED.
Patient problems: Pain
MAUDE report 9779364 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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