MALLORY/HEAD PRIMARY HIP SYSTEM 11-104209Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304010253), received between Sep 28, 2021 and Dec 28, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Erosion” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K000538, K003429, K030055); 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.

• InjuryDec 28, 2021Material Erosion; Material Erosion

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Dizziness; Failure of Implant; Metal Related Pathology; Pain

  MAUDE report 13098317 ↗
• InjurySep 28, 2021Material Erosion; Material Erosion

  IT WAS REPORTED THE PATIENT UNDERWENT A HIP ARTHROPLASTY AND SUBSEQUENTLY 5 YEARS LATER IS EXPERIENCING PAIN, LOSS OF BALANCE, DIZZINESS, ELEVATED METAL IONS, DIFFICULTY IN WALKING AND UPSET STOMACH DUE TO THE DETERIORATION AND FAILURE OF IMPLANT. NO REVISION HAS BEEN REPORTED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Dizziness; Metal Related Pathology; Nausea; Pain

  MAUDE report 12543324 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000538, K003429, K030055. One submission often covers many models, so check the product and lot details in each record.

• Z-0523-2020 · Aug 21, 2019 · Terminated
  Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-103204 21-103205 21-103206 21-103207 21-1
• Z-1754-2015 · Apr 16, 2015 · Terminated
  Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral
• Z-1122-2015 · Jan 9, 2015 · Terminated
  Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)