M2A MAGNUM HIP SYSTEM US157852Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304449442), received between Mar 4, 2022 and Mar 4, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION AND INSTABILITY APPROXIMATELY 2 DAYS POST REVISION SURGERY. THE HEAD AND CUP WERE EXCHANGED WITH COMPETITOR PRODUCTS WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 13667081 ↗
• InjuryMar 4, 2022Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ELEVATED METAL IONS, EFFUSION AND ADVERSE LOCAL TISSUE REACTION (ALTR) APPROXIMATELY 13 YEARS POST IMPLANTATION. DURING THE REVISION, AN ABDUCTOR TEAR AND TROCHANTERIC BURSA METAL DEBRIS WERE NOTED. METAL DEBRIS NOTED TO THE POSTERIOR CAPSULE AND BENEATH THE GREATER TROCHANTER. THE HEAD AND TAPER ADAPTER WERE EXCHANGED WITHOUT COMPLICATIONS. FEMORAL HEAD TRUNNION HAD <20% AREA OF DULLING. THE STEM AND CUP REMAINED IMPLANTED. IT WAS NOTED THE STABILITY CHECK SHOWED NO STABILITY POSTERIORLY AND ANTERIORLY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Metal Related Pathology; Muscle/Tendon Damage; Swelling/ Edema

  MAUDE report 13666994 ↗

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 · Terminated
  Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.