GLADIATOR® BIPOLAR GLBP2845Recalls & reported problems
Microport Orthopedics Inc. · GLADIATOR® BIPOLAR 45MM OD X 28MM ID · Class 2 · Implant
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 M684GLBP28451), received between Feb 7, 2020 and Aug 1, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Difficult to Insert” (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
- Difficult to Insert1
- Fitting Problem1
- Insufficient Device Problem Information1
Patient problems
- No Information1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT DEVELOPED AN INFECTION AND UNDERWENT A REVISION SURGERY TO REVISE THE ELEOS FEMORAL HEAD AND MICROPORT GLADIATOR BIPOLAR.
Patient problems: Unspecified Infection
MAUDE report 17439420 ↗InjuryFeb 7, 2020Difficult to Insert; Fitting Problem; Difficult to Insert; Fitting Problem
ALLEGEDLY, SHELL DID NOT ATTACH TO THE BALL. ADDITIONAL INFORMATION ON 01/31/2020: REPORTER STATED THAT DURING SURGERY THE HEAD DID NOT ATTACH TO THE SHELL. THEY WERE USING A 28 HEAD AND A 45 BIPOLAR SHELL. ACCORDING TO THE REPORTER, HE NOTICED THAT THE PLASTIC RIM INSIDE THE SHELL DID NOT SEEM FLUSH TO THE SHELL (THERE WAS A 3-4MM GAP) AND HE THINKS THAT IT MAY BE THE REASON WHY THE HEAD DID NOT ATTACH TO THE SHELL. IN THE END, THEY USED A 32 HEAD AND A 46 SHELL. THESE FUNCTIONED WELL.
Patient problems: No Information
MAUDE report 9682724 ↗
Other Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 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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