GUARDIAN® 2500CC13Recalls & reported problems
Microport Orthopedics Inc. · GUARDIAN® CEMENTED STEM LG COLLAR 152MM X 13MM · Class 2 · Implant
All models of GUARDIAN (22)
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 M6842500CC131), received between Oct 30, 2019 and Apr 13, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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
- Appropriate Device Problem Term/Code Not Available1
- Loose or Intermittent Connection1
- Loss of Osseointegration1
Patient problems
- No Information1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2022Appropriate Device Problem Term/Code Not Available
ALLEGEDLY, IN THE REVISION ON (B)(6) 2022 DR. (B)(6) REMOVED THE FEMUR, MIDSECTION, STEM, POLY, AND HINGE AND REPLACED IT WITH NEW PARTS BECAUSE THE PATIENT WAS COMPLAINING OF SOME PAIN.
Patient problems: Pain
MAUDE report 14105340 ↗InjuryOct 30, 2019Loose or Intermittent Connection; Loss of Osseointegration; Loose or Intermittent Connection; Loss of Osseointegration
ALLEGEDLY, PATIENT UNDERWENT A REVISION SURGERY DUE TO THE SEGMENTAL STEM LOOSENING.
Patient problems: No Information
MAUDE report 9256314 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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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