AML 1554-05-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295058526), received between Feb 5, 2020 and Jul 2, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Degraded” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2024Degraded; Degraded

  MEDICAL RECORDS RECEIVED AD 18 JUN 2024. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED WAS DUE TO ADVERSE REACTION TO METAL DEBRIS RIGHT HIP. PRIOR TO REVISION PATIENT MRI SHOWED FAILED PSEUDOTUMOR BUT SHE HAD A LARGE FLUID COLLECTION AT THE TROCHANTER WITH AVULSION OF THE ANTERIOR GLUTEI. PAIN HAS BEEN STABLE BUT INTERMITTENT IN SEVERITY AND COMPLAINTS AUDIBLE GRINDING. THERE IS A SLIGHT LIMP. OPERATIVE NOTES INDICATED UPON REMOVING THE HEAD THERE WAS A TREMENDOUS AMOUNT OF METALLIC, BLACK DEBRIS AT THE TRUNNION. DOI: (B)(6) 2006. DOR: (B)(6) 2012. RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 19655664 ↗
• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT HIP REVISION SURGERY. DURALOC ENDURANCE LINER WAS COMPLETELY WORN THROUGH CAUSING THE RELEASE OF METAL AND PLASTIC DEBRIS. SURGEON REPLACED CUP, LINER AND HEAD COMPONENT.

  Patient problems: Foreign Body Reaction

  MAUDE report 18864592 ↗
• InjuryFeb 5, 2020Degraded; Degraded

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED METAL ON METAL SOFT TISSUE IRRITATION AND REACTION. OPERATIVE NOTES INDICATED INCREASING PAIN WITH A LITTLE LIMP. UPON ENTERING THE HIP JOINT ITSELF, ABUNDANT AMOUNT OF ORANGISH FLUID WAS PRESENT. NO PURULENCE BUT SORT OF THE TYPICAL METAL ON METAL REACTION. THERE WAS SOME OF USUAL REACTIVE ALMOST SAWDUST LIKE TISSUE IN THE CAPSULE. THERE WAS SOME CORROSION PRODUCTS ON THE TRUNNION BUT NO OBVIOUS DAMAGE ITSELF. DOI: (B)(6) 2004; DOR: (B)(6) 2018 LEFT HIP. PLEASE SEE (B)(4) RIGHT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; No Code Available; Pain

  MAUDE report 9671327 ↗