AML 1557-04-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295059257), received between Jul 11, 2018 and Nov 7, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION PAPERS ALLEGE THAT AFTER THE SURGERY, FRICTION AND WEAR BETWEEN THE COBALT-CHROMIUM METAL HEAD AND COBALT-CHROMIUM METAL LINER CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PATIENT'S BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. AS A RESULT, PATIENT HAS BEEN EXPERIENCING SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HIS RIGHT AND 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. IT IS FURTHER ALLEGED THAT THE PATIENT WILL LIKELY NEED TO UNDERGO REVISION SURGERY TO REPLACE THE IMPLANT. DOI: (B)(6) 2003 - DOR: NONE REPORTED (RIGHT HIP); DOI: (B)(6) 2003 - DOR: NONE REPORTED (LEFT HIP). PATIENT IS RESIDENT OF (B)(6). UPDATE AD 1 MAY 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. PPF HAS NO ALLEGATION AND NO REVISION REPORTED. THE UNKNOWN DEPUY PINNACLE HIP THAT WAS REPORTED IN THE WPC WAS CHANGED TO PINNACLE METAL LINER. ADDED HEAD AND STEM DUE TO A LARGE AMOUNT OF TOXIC COBALT CHROMIUM. UPDATED DOB AND ADDED LAW FIRM IN THE FACILITY NAME. THE PATIENT UNDERWENT BILATERAL TOTAL HIP ARTH

  Patient problems: Discomfort; Inflammation; Pain; Test Result

  MAUDE report 8045577 ↗
• InjuryJul 11, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT PRESENTED WITH PAINFUL LEFT HIP. UPON EXAMINATION AND TESTS, DR. (B)(6) BELIEVED THE FEMORAL STEM TO BE UNDERSIZED FOR THE PATIENT¿S ANATOMY AND LOOSE AS WELL. DURING SURGERY, DR (B)(6) DETERMINED THE FEMORAL STEM WAS LOOSE AS A RESULT OF BEING UNDERSIZED. HE REMOVED THE INDEX FEMORAL HEAD AND STEM AND REPLACED WITH A COMPETITORS. HE REPLACED THE DURALOC ACETABULAR LINER SINCE HE WAS THERE AND HOPED THAT WOULD EXTEND THE LIFE OF THE CONSTRUCT FOR THE PATIENT.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 7679454 ↗