AML 1554-03-165Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295058465), received between Dec 18, 2014 and Feb 15, 2023 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Packaging Compromised” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 15, 2023Migration; Migration

  PATIENT WAS REVISED DUE TO STEM SUBSIDED. THERE WAS NO SURGICAL DELAY. DOI - UNKNOWN. DOR - (B)(6) 2023. AFFECTED SIDE - LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 16378397 ↗
• InjuryJul 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FX FEMUR AT THE DISTAL TIP OF THE STEM POST SURGERY. NEEDED CABLES AND PLATE TO FIX. THE AML STEM STAYED IN. DOE: (B)(6) 2021 (LEFT HIP).

  Patient problems: Limb Fracture

  MAUDE report 12245423 ↗
• InjuryMar 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECORD RECEIVED. PPF ALLEGES DISLOCATION, INFECTION AND ELEVATED METAL IONS. DOI: (B)(6) 2011; DOR: (B)(6) 2013; (LEFT HIP).

  Patient problems: No Code Available; Test Result; Unspecified Infection

  MAUDE report 8381714 ↗
• InjuryAug 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEW UNITY RECORD CREATED IN ORDER TO UPDATE ETQ COMPLAINT NUMBER (B)(4). NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT.- LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM LARGE AMOUNTS OF TOXIC AMOUNTS OF COBALT CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE PATIENTS BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANT. IT IS ALSO ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, LIMITED MOBILITY, AND WEAKNESS. PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. SALES REP HAS REPORTED A REVISION DUE TO INSTABILITY. COMPLAINT WAS UPDATED (B)(6) 2017. (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS RECEIVED. THERE IS NO NEW ALLEGATION AND REVISION REPORTED. ADDED STEM DUE TO PREVIOUSLY ALLEGED TOXIC AMOUNTS OF COBALT CHROMIUM METAL IONS. ADDED LAWYER AND LAW FIRM. DOI: (B)(6) 2008 - DOR: (B)(6) 2017(RIGHT HIP).

  Patient problems: Discomfort; Limited Mobility Of The Implanted Joint; Not Applicable; Pain; Test Result; Weakness

  MAUDE report 7832281 ↗
• InjuryFeb 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY LEGAL THAT PATIENT WAS REVISED ON (B)(6) 2010 AND THE FOLLOWING WAS PERFORMED DURING SURGERY DEBRIDEMENT OF THE TROCHANTER BURSA, HIP ARTHROTOMY, DEBRIDEMENT OF FIBROUS TISSUE SURROUNDING THE HIP, SLIGHT METALLOSIS. SURGERY WAS WELL TOLERATED. PRIOR TO REVISION PATIENT EXPERIENCED BURNING PAIN, LOOSENING OF THE PROSTHESIS VS ABDUCTOR MUSCLE INJURY, BILATERAL SCIATALGIA AND BURSITIS. FOLLOWING SURGERY THE PAIN PERSISTED AND ON (B)(6) 2010 PATIENT WAS REVISED WHICH INCLUDED A CONVERSION FROM METAL TO POLYETHYLENE IMPLANT. A VERY THICK PSEUDO CAPSULE AND EFFUSION WERE NOTED DURING SURGERY. THE SURGERY WAS TOLERATED WELL BUT THERE IS A HIP METAL HYPERSENSITIVITY. AD (B)(6) 2018: TRANSLATED MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE PATIENT WAS REVISED TO ADDRESS METAL HYPERSENSITIVITY. CLINICAL NOTES REPORTED OF PAIN, SLIGHT METALLOSIS, BURSITIS, ELEVATED METAL IONS, AND LOOSENING OF ABDUCTOR MUSCLE INJURY.

  Patient problems: Hypersensitivity/Allergic reaction; Injury; Pain; Tissue Damage

  MAUDE report 7302258 ↗
• MalfunctionJan 12, 2018Device Packaging Compromised; Device Packaging Compromised

  DER STATE THAT THE AML 16.5MM HIGH OFFSET STEM PACKAGING WAS CRACKED AND PRODUCT WAS NOT STERILE IN PACKAGING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7185589 ↗
• InjuryDec 18, 2014Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  LITIGATION PAPERS RECEIVED. IT IS ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, INFLAMMATION, DISCOMFORT, DIFFICULTY AMBULATING, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. UPDATE 11/20/2014- PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED METAL DEBRIS, PAIN, INCREASED METAL IONS (NO LAB RESULTS PROVIDED), PSEUDOCYST, AND GRANULAR NECROTIC TISSUE. THE STEM IS BEING ADDED FOR THE HIGH METAL IONS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 12/18/2014.

  Patient problems: No Information

  MAUDE report 4341814 ↗