GLADIATOR® BIPOLAR GLBP3249Recalls & reported problems
Microport Orthopedics Inc. · GLADIATOR® BIPOLAR 49MM OD X 32MM ID · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M684GLBP32491), received between Mar 10, 2020 and Apr 5, 2021 — classified as 3 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component3
- Device Dislodged or Dislocated1
Patient problems
- No Information2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 5, 2021Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
ALLEGEDLY, BIPOLAR DISLOCATED FROM FEMORAL HEAD BALL. PATIENT DISLOCATED HIP AND BIPOLAR SHELL CAME DISASSOCIATED FROM HEAD PROBABLY DURING RELOCATION OF HIP.
Patient problems: Insufficient Information
MAUDE report 11613092 ↗InjuryMar 11, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ALLEGEDLY, THE PATIENT FELL AND DISLOCATED, DURING CLOSED REDUCTION THE BIPOLAR DISASSOCIATED, AND THEN THE PATIENT WAS REVISED. REFERENCE (B)(4).
Patient problems: No Information
MAUDE report 9821721 ↗InjuryMar 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ALLEGEDLY, PATIENT FELL AGAIN, DISLOCATED AND THE BIPOLAR DISASSOCIATED.. THERE HAS NOT BEEN A CONFIRMED REVISION FOR THIS INCIDENT. REFERENCE (B)(4) AS A PREVIOUS INCIDENT FOR THIS PATIENT.
Patient problems: No Information
MAUDE report 9813958 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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