M2A MAGNUM HIP SYSTEM US157850Recalls & 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 00880304449435), received between Aug 21, 2017 and Aug 21, 2017 — 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
- Metal Shedding Debris1
Patient problems
- Discomfort1
- Metal Related Pathology1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 21, 2017Material Erosion; Metal Shedding Debris; Material Erosion; Metal Shedding Debris
IT WAS REPORTED THE PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY THREE YEARS POST-IMPLANTATION DUE TO PAIN, DISCOMFORT, AND ELEVATED METAL ION LEVELS.IT WAS ADDITIONALLY REPORTED THAT DURING THE REVISION PROCEDURE METALLOSIS WITH WEAR DEBRIS, TRUNNIONIS, AND ABDUCTOR MUSCLE TEAR WERE IDENTIFIED. MILD DISCOLORATION WAS OBSERVED ON THE TRUNNION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: Discomfort; Metal Related Pathology; Pain
MAUDE report 6806697 ↗
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.
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