M2A MAGNUM HIP SYSTEM US157854Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304449510), received between Jul 15, 2016 and Jul 15, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Material Erosion” (1 report).
1 other recall cover devices cleared under the same FDA submission (K101336); they may or may not involve this specific model.
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
- Material Erosion1
- Migration or Expulsion of Device1
Patient problems
- Metal Related Pathology1
- Pain1
- Reaction1
- Tissue Damage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 15, 2016Material Erosion; Migration or Expulsion of Device; Material Erosion; Migration or Expulsion of Device
PATIENT'S LEGAL COUNSEL REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 8 YEARS POST-IMPLANTATION DUE TO METALLOSIS AND LOOSENING. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. REVIEW OF MEDICAL RECORDS REVEALS THAT THE PATIENT HAD LOOSENING OF THE ACETABULAR CUP AND TISSUE DAMAGE WITH FLUID AND THICKENING OF THE CAPSULAR LINING. REVIEW OF INVOICE HISTORY REVEALED THAT THE FEMORAL HEAD WAS REMOVED AND REPLACED. THE ACETABULAR CUP WAS REMOVED AND REPLACED WITH A COMPETITOR ACETABULAR CUP AND LINER.
Patient problems: Metal Related Pathology; Pain; Reaction; Tissue Damage
MAUDE report 5799421 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K101336. One submission often covers many models, so check the product and lot details in each record.
- Z-1465-2013 · Apr 26, 2013 · TerminatedActive Articulation E1. Intended for use with either primary or revision hip arthroplasty.
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.
How reports and recalls are matched · Editorial policy · Report an error on this page