AML 1554-01-165Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295058267), received between Oct 8, 2015 and Dec 2, 2025 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2025Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING AND SUBSIDENCE OF FEMORAL STEM. LOOSENING INTERFACE: UNKNOWN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23692874 ↗
• InjuryDec 2, 2021Degraded; Degraded

  UNFILED CLAIM AND PINNACLE MOM MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED DUE TO METAL WEAR AND CORROSION AND PAIN. OPERATIVE NOTE REPORTED TAPER JUNCTION CORROSION AT THE STEM. THERE WAS JOINT FLUID VISIBLE AS BURSAL FLUID, SLIGHTLY GRAY COLOR SUGGESTIVE OF METAL STAINING, CORROSION BOTH IN NECK AND THE TAPER OF THE HEAD. HOWEVER THERE WAS NO GROSS WEAR OF THE ARTICULATING SURFACE. PATHOLOGY REPORT MINOR CORROSION TO NECK OF FEMORAL COMPONENT, PROTEINACEOUS MATERIAL BETWEEN CUP AND LINER, BURSA OVER THE GREATER TROCH. DOI: (B)(6) 2011; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Foreign Body Reaction; Pain; Swelling/ Edema

  MAUDE report 12916123 ↗
• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, IT WAS NOTICED THAT THE ANTERIOR FEMORAL NECK WAS NOTED TO HAVE CRACKED. DOE: (B)(6) 2010.

  Patient problems: Bone Fracture(s)

  MAUDE report 11125216 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED METAL IONS. OPERATIVE NOTE REPORTED FIBROUS SCAR TISSUE. THERE WAS CLEAR FLUID NOTED AND SCAR WITHIN THE JOINT AND PSEUDOCAPSULE SCAR.

  Patient problems: Adhesion(s); Fibrosis; Hypersensitivity/Allergic reaction; No Code Available; Pain

  MAUDE report 9813443 ↗
• InjuryMar 9, 2020Degraded; Degraded

  PINNACLE MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS FAILED LEFT THA. OPERATIVE NOTE REPORTED MOM ARTICULATION, SYNOVIAL FLUID AND SCAR TISSUE OVER THE TROCHANTER. NOTED CORROSION AROUND TRUNNION AND FEMORAL HEAD. DOI: (B)(6) 2009; DOR: (B)(6) 2015; LEFT HIP.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9808605 ↗
• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT PATIENT EXPERIENCED SEVERE PAIN OVER A PERIOD OF TIME, WHICH HINDERED HER ABILITY TO WALK AND REQUIRED VARIOUS PAIN MEDICATIONS. HER PHYSICIAN DETECTED HIGH METAL LEVELS IN HER BLOOD. DOI: (B)(6) 2008 - DOR: NONE REPORTED (LEFT HIP). **PATIENT IS A RESIDENT OF (B)(6) UPDATE: 10/10/2012 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE AD 10 SEP 2019. (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND STICKER SHEETS VIA CD SHIPMENT AD 25 SEP. PPF ALLEGES INFECTION REQUIRING IV ANTIBIOTICS, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2008 - DOR: NOT REVISED (LEFT HIP).

  Patient problems: Foreign Body Reaction; Pain; Test Result; Unspecified Infection

  MAUDE report 9140215 ↗
• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AD (B)(6) 2019. (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND STICKER SHEETS VIA CD SHIPMENT AD (B)(6) 2018. PPF ALLEGES INFECTION REQUIRING IV ANTIBIOTICS, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2008; DOR: (B)(6) 2011; (RIGHT HIP).

  Patient problems: Foreign Body Reaction; No Code Available; Pain; Test Result; Unspecified Infection

  MAUDE report 9140084 ↗
• InjuryMar 13, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM SEVERE PAIN, DISCOMFORT, INFLAMMATION, AND A POPPING/SNAPPING SENSATION. UPDATE 10/18/2012: RECORDS INDICATE THAT THE PATIENT WAS REVISED BECAUSE OF INFECTION. PATIENT WAS REVISED TO ADDRESS CHRONIC PAIN, DISCOMFORT, AND INFECTION. UPDATE REC'D 5/12/2014 - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE. UPDATE AD 26 FEB 2019: RECEIPT OF PPF AND MEDICAL RECORDS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGED PSEUDOTUMOR. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS INFECTED LEFT TOTAL HIP ARTHROPLASTY, INCREASING PAIN IN THE LEFT HIP, PATIENT HAD A WORKUP, WHICH WAS CONSISTENT WITH LOOSENING. PATIENT EXPERIENCED PAIN, LOOSENING OF THE PROSTHESIS, AND SUBSIDENCE. OPERATIVE REPORTED THERE WAS SCARRING WITHIN SUPERFICIAL AND DEEP TISSUES.

  Patient problems: Discomfort; Inflammation; Joint Disorder; No Code Available; Pain; Test Result; Tissue Damage; Unspecified Infection

  MAUDE report 8416184 ↗
• InjuryMar 14, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PATIENT WAS REVISED TO ADDRESS AN UNTREATED INFECTION FOR SOME TIME. SURGEON REMOVED ALL IMPLANTS AND REPLACED WITH A ANTIBIOTIC SPACER. IT WAS STATED THAT THERE WAS LOOSENING FROM BONE TO IMPLANT INTERFACE. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 7338062 ↗
• InjuryOct 8, 2015Corroded; Metal Shedding Debris

  LITIGATION ALLEGES PATIENT SUFFERS FROM TOXIC COBALT CHROMIUM METAL DEBRIS, PAIN, DISCOMFORT, AND INFLAMMATION.

  Patient problems: Discomfort; Foreign Body Reaction; Host-Tissue Reaction; Inflammation; Joint Swelling; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; No Code Available; Pain; Synovitis

  MAUDE report 5135827 ↗