Profemur PHA00238Recalls & reported problems
Microport Orthopedics Inc. · PROFEMUR Z SIZE 4 STEM · Class 2 · Implant
All models of PROFEMUR (116)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M684PHA002381), received between Mar 31, 2020 and Feb 5, 2025 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Adverse Event Without Identified Device or Use Problem1
- Corroded1
- Device Dislodged or Dislocated1
Patient problems
- No Information3
- Bone Fracture(s)1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryFeb 5, 2025Corroded; Corroded
ALLEGEDLY, ON (B)(6) 2023, THE PATIENT VISITED A DOCTOR BECAUSE SHE WAS HAVING PAIN. AT THAT TIME, SHE WAS DIAGNOSED WITH A GLUTEUS MEDIUS TENDON TEAR. ON (B)(6) 2023, THE DOCTOR INFORMED HER THAT THE CHROMIUM LEVEL IS 0.8, AND HER COBALT LEVEL IS 2.7, ABOVE 1 PPB THRESHOLD. THE DOCTOR INFORMED HER THAT AT THIS POINT IN TIME, THEY WILL WAIT FOR HER TITANIUM LEVEL TO COME BACK. IF HER TITANIUM LEVEL IS ABOVE 10, THIS WOULD BE CONCERNING FOR MECHANICALLY ASSISTED CREVICE CORROSION AT THE NECK-STEM TAPER JUNCTION. OVER THE NEXT YEAR IT WAS DETERMINED THAT HER COBALT AND CHROMIUM LEVELS WERE NOT STABLE. DURING THE REVISION SURGERY THE DOCTOR FOUND: FAILED RIGHT TOTAL HIP ARTHROPLASTY; RIGHT HIP, ABDUCTOR TEAR AND METAL DEBRIS WAS NOTED AT THE STEM-NECK JUNCTION. NON MPO PRODUCTS: PRODUCT ID: 6230040E X3 LINERS/ LOT NO.: MICRVN9/ QTY: 1. PRODUCT ID: 5000354E X3 STRYKER TRIDENT ACETABULAR SYSTEM/ LOT NO.: NI/ QTY: 1.
Patient problems: Pain
MAUDE report 21314138 ↗MalfunctionOct 28, 2021Adverse Event Without Identified Device or Use Problem
ALLEGEDLY, INTRAOPERATIVE BONE FRACTURE OF THE FEMUR OCCURRED DURING STEM INSERTION. (B)(4).
Patient problems: Bone Fracture(s)
MAUDE report 12713526 ↗InjuryMay 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO UNKNOWN.
Patient problems: No Information
MAUDE report 10085254 ↗InjuryApr 16, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
ALLEGEDLY, PATIENT WAS REVISED DUE TO RECURRENT PROSTHESIS DISLOCATION.
Patient problems: No Information
MAUDE report 9967993 ↗MalfunctionMar 31, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO UNKNOWN.
Patient problems: No Information
MAUDE report 9903223 ↗
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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