AML 1554-02-180Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295058397), received between Nov 5, 2018 and Sep 16, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

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

• InjurySep 16, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: UNKNOWN. DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 9072430 ↗
• InjuryJan 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTED RIGHT TOTAL HIP ARTHROPLASTY. DOI: (B)(6) 2007 - DOR: (B)(6) 2007 (RIGHT HIP).

  Patient problems: Unspecified Infection

  MAUDE report 8230741 ↗
• InjuryNov 5, 2018Biocompatibility; Biocompatibility

  LITIGATION ALLEGE: LARGE AMOUNTS OF COBALT CHROMIUM METAL IONS AND PARTICLES IN HIS BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANT. PATIENT HAS BEEN EXPERIENCING SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HIS LEFT THIGH AND GROIN. HE ALSO EXPERIENCES A POPPING AND SNAPPING SENSATION IN HIS HIP-JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. UPDATE AD 01 MAY 2018: RECEIPT OF PPF AND STICKER SHEETS RECORD. PPF HAS NO NEW ALLEGATION.

  Patient problems: Discomfort; Inflammation; No Code Available; Pain; Test Result

  MAUDE report 8038648 ↗