PROFEMUR® PRGLDC04Recalls & reported problems
Microport Orthopedics Inc. · PROFEMUR® GLADIATOR® DISTAL CENTRALIZER 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 M684PRGLDC041), received between Sep 7, 2020 and Jun 25, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Use of Device Problem1
Patient problems
- Bone Fracture(s)1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 25, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
(B)(6): ALLEGEDLY, THE PATIENT HAD A LUXATION OF THE RIGHT HIP WITH PERIPROSTHETIC FRACTURE. JOINT REDUCTION PERFORMED ON (B)(6) 2017. (B)(6): ALLEGEDLY, PATIENT SAT ON THE SOFA. WHEN LIFTING THE RIGHT LEG, THE HIP LUXATED. RECOVERED AFTER REMOVING HEAD AND MODULAR NECK OF THE RIGHT HIP. BFARM CASE NUMBER: (B)(4).
Patient problems: Bone Fracture(s)
MAUDE report 12071436 ↗InjurySep 7, 2020Use of Device Problem; Device Dislodged or Dislocated; Use of Device Problem; Device Dislodged or Dislocated
ALLEGEDLY, PATIENT WAS SQUATTING WHICH LEAD OUT A LUXATION OF THE IMPLANTED HIP; LATER IT COULD BE REPOSITIONED BY CLOSED REPOSITION.
Patient problems: No Information
MAUDE report 10499554 ↗
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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