AML 1554-03-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295058441), received between Apr 6, 2018 and Sep 21, 2020 — classified as 12 injuries.

The most frequently reported specific device problem is “Corroded” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2020Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT FELL AND FRACTURED THE FEMUR (PERIPROSTHETIC FRACTURE).

  Patient problems: Bone Fracture(s); Fall; No Code Available

  MAUDE report 10560303 ↗
• InjuryJul 22, 2020Corroded; Degraded; Corroded; Degraded

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED ON (B)(6) 2020. OPERATIVE NOTES REPORTED THAT UPON ENTERING THE JOINT CAPSULE, BROWN-TINGED FLUID WAS ENCOUNTERED CONSISTENT WITH METALLOSIS. THERE WAS SIGNIFICANT METALLOSIS AND CAKING OF BLACK MATERIAL WERE NOTE SURROUNDING THE TRUNNION. DOI: (B)(6) 2009; DOR: (B)(6) 2020; RIGHT HIP. THE PATIENT HAS BILATERAL HIP IMPLANTS, PLEASE SEE (B)(4) FOR THE LEFT HIP.

  Patient problems: Edema; Foreign Body Reaction; No Code Available; Tissue Damage

  MAUDE report 10309991 ↗
• InjuryApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES METALLOSIS, METAL WEAR AND ELEVATED METAL IONS. DOI: (B)(6) 2010; DOR: (B)(6) 2015; RIGHT HIP.

  Patient problems: No Code Available; Test Result; Tissue Damage

  MAUDE report 8562524 ↗
• InjuryApr 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES ELEVATED METAL IONS AFTER FIRST REVISION. DOI: (B)(6) 2011 - DOR : NONE REPORTED, (RIGHT HIP).

  Patient problems: Test Result

  MAUDE report 8487230 ↗
• InjuryMar 28, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT SUFFERED A FRACTURE DISTAL TO HER AML STEM, SO THE STEM WAS REMOVED AND REPLACED WITH A REVISION STEM. THE LINER WAS ALSO EXCHANGED. ORIGINAL SURGERY DATE/LOCATION UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 8460718 ↗
• InjuryNov 16, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  PPF ALLEGES PSEUDOTUMOR AND METALLOSIS. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS FAILED METAL ON METAL HIP REPLACEMENTS, BILATERAL HIPS. REVISION NOTE REPORTED ELEVATED COBALT CHROMIUM LEVELS, MODERATE DISCOMFORT IN THE RIGHT AND SYNOVITIS.

  Patient problems: Discomfort; Edema; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Hypoesthesia; Inflammation; Injury; Not Applicable; Pain; Synovitis; Test Result

  MAUDE report 8077838 ↗
• InjuryNov 16, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  PPF ALLEGES PSEUDOTUMOR AND METALLOSIS. AFTERE REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS FAILED METAL ON METAL HIP REPLACEMENTS, BILATERAL HIPS. REVISION NOTE REPORTED ELEVATED COBALT CHROMIUM LEVELS, SYNOVITIS, METALLOSIS, EFFUSION AND IT IS ALSO MENTION THAT THERE WAS NO SIGNS OF PUS OR INFECTION.

  Patient problems: Discomfort; Edema; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Injury; Not Applicable; Pain; Synovitis; Test Result

  MAUDE report 8077811 ↗
• InjuryOct 26, 2018Corroded; Corroded

  NEW UNITY RECORD CREATED IN ORDER TO UPDATE LEGACY COMPLAINT NUMBER (B)(4). LITIGATION PAPERS ALLEGE THAT CORROSION AND FRICTION WEAR CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE PATIENT'S BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. IT IS FURTHER ALLEGED THAT THE PATIENT HAS EXPERIENCED SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HIS LEFT THIGH AND HIP AREA, AS WELL AS HIS GROIN. PATIENT HAS EXPERIENCED EPISODES OF A GRINDING AND POPPING SENSATION IN HIS LEFT HIP. DOI: (B)(6) 2007; DOR: NONE REPORTED (LEFT HIP). PATIENT IS A RESIDENT OF (B)(6). UPDATE AD 01 MAY 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. THERE WERE NO NEW ALLEGATIONS OR REVISIONS REPORTED. ADDED STEM DUE TO PREVIOUSLY ALLEGED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS. ADDED PATIENT'S DOB, AGE, LAW FIRM AND LAWYER IN THE ASSOCIATED CONTACT. UPDATED PART AND LOT NUMBERS OF THE IMPACTED PRODUCTS. DOI: (B)(6) 2007; DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Discomfort; Inflammation; Pain; Test Result

  MAUDE report 8009355 ↗
• InjuryOct 4, 2018Corroded; Degraded; Appropriate Device Problem Term/Code Not Available; Corroded; Degraded; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS DISASSOCIATION OF THE METAL LINER FROM THE CUP AND RELATED PAIN. UPDATE AD 10 SEP 2018: LITIGATION ALLEGES ELEVATED BLOOD METAL LEVELS AND INJURY WHICH INHIBITED THE PATIENT'S ABILITY TO MOVE. THE LAW FIRM AND LAWYER WERE ADDED TO THIS COMPLAINT. AN IMPACTED PRODUCT RECORD FOR THE STEM AND HEAD WAS ADDED DUE TO THE ALLEGED ELEVATED METAL ION LEVELS.

  Patient problems: Host-Tissue Reaction; Injury; Limited Mobility Of The Implanted Joint; Not Applicable; Pain; Test Result

  MAUDE report 7933611 ↗
• InjuryMay 25, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  COMPLAINT DESCRIPTION: LITIGATION ALLEGES PATIENT SUFFERS FROM "TISSUE WITH A DARK GRAYISH COLOR WITH A PIGMENTED NODULAR SYNOVITIC APPEARANCE," UPON REVISION. ALTHOUGH NO PATIENT SPECIFIC ALLEGATIONS WERE GIVEN, GENERAL LITIGATION ALLEGES METAL ON METAL, SO WE ARE REPORTING THE LINER AND HEAD. UPDATE AD (B)(6) 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PPF RECORDS. PPF ALLEGES ELEVATED METAL IONS AND METAL WEAR/METALLOSIS. THE EVENT DESCRIPTION HAS BEEN UPDATED TO INDICATE THE ALLEGATIONS AS REVIEWED. THE LAW FIRM NAME,PRODUCT DETAILS AND PATIENT HARM WERE UPDATED AS WELL. DOI: (B)(6) 2010; DOR: (B)(6) 2013; LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Fall; Foreign Body Reaction; Inflammation; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Not Applicable; Pain; Test Result; Tissue Damage

  MAUDE report 7544396 ↗
• InjuryMay 7, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED COBALT-CHROMIUM LEVELS. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED COBALT-CHROMIUM LEVELS. OPERATIVE NOTE REPORTED THAT THE PATIENT HAVE A SIGNIFICANT LARGE EFFUSION AND HAVE METAL-STAINED SYNOVIAL LINING. THERE IS NO LAB RESULTS FOR THE ALLEGED ELEVATED METAL IONS. DOI: (B)(6) 2011; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: No Code Available; Not Applicable; Pain; Tissue Damage

  MAUDE report 7490170 ↗
• InjuryApr 6, 2018Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  OCT 27, 2017: LITIGATION RECEIVED. LITIGATION ALLEGES SEVERE PAIN, LIMITED MOBILITY, INABILITY TO PERFORM ADL, AND METALLOSIS.

  Patient problems: Host-Tissue Reaction; Inadequate Osseointegration; Loss of Range of Motion; Not Applicable; Osteolysis; Pain; Tissue Damage

  MAUDE report 7402594 ↗