AML 1554-01-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10603295058243), received between Aug 17, 2017 and Dec 2, 2024 — classified as 27 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (8 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE FRACTURE OF FEMORAL STEM. DOI: (B)(6) 2007. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Limb Fracture

  MAUDE report 20818046 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR LITIGATION RECORD RECEIVED. LITIGATION ALLEGES SEVERE PAIN, DISCOMFORT, ELEVATED METAL IONS, EMOTIONAL DISTRESS, DISABILITY, DISFIGUREMENT, PERSONAL AND ECONOMIC INJURIES. DOI: (B)(6) 2007; DOR: (B)(6) 2023; LEFT HIP.

  Patient problems: Deformity/ Disfigurement; Discomfort; Distress; Metal Related Pathology; Pain

  MAUDE report 18430566 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AND REPORTED THAT ON (B)(6) 2015, THE PATIENT HAD A LEFT THR, TO ADDRESS END-STAGE JOINT DISEASE, COMPLETE JOINT DESTRUCTION, BONE-ON-BONE LEFT HIP. ON (B)(6) 2021 CHROMIUM 20.1 NG/ML AND COBALT 49.5 NG/ML. ON (B)(6) 2021 PROGRESS NOTES STATE THE PATIENT REPORTS HAVING BILATERAL HIP PAIN. DOI: (B)(6) 2015; DOE: (B)(6) 2021; LEFT HIP.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 16805941 ↗
• InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS METALLOSIS AND PAIN . OPERATIVE NOTE REPORTED SOME TURBID FLUID, LARGE PROLIFERATION OF METALLOSED SYNOVIAL TISSUE. SYNOVECTOMY WERE PERFORMED REMOVING METAL STAINED SYNOVIAL TISSUE. THERE WAS SOME BONE DEFECTS. DOI: (B)(6) 2009; DOR: (B)(6), 2020; RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Deformity/ Disfigurement; Discomfort; Distress; Foreign Body Reaction; Metal Related Pathology; Pain; Swelling/ Edema; Synovitis; Unspecified Tissue Injury

  MAUDE report 14318088 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION COMPLAINT RECEIVED AD 13 APR 2022. PATIENT WAS REVISED WAS DUE TO HEAVY METAL POISONING FROM TOXIC HEAVY METALS. ALSO ALLEGES INJURY, PAIN, TISSUE DESTRUCTION, METAL WEAR, LOSS OF ENJOYMENT OF LIFE AND LIMITATION OF DAILY ACTIVITIES. DOI: (B)(6) 2006; DOR: (B)(6) 2021 UNK HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Joint Laxity; Loss of Range of Motion; Metal Related Pathology; Osteolysis; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 14250606 ↗
• InjuryMar 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT AML STEM REVISED DUE TO PAIN. NO ADDITIONAL INFORMATION. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 13684545 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AS "PATIENT SUFFERED A PERIPROSTHETIC FRACTURE DISTAL TO THE STEM. SURGEON REMOVED STEM AND REPLACED WITH A BIOMETRIC STEM AND A PINNACLE DUAL MOBILITY HEAD AND LINER. DOI: (B)(6) 2017. DOR: (B)(6) 2021; AFFECTED SIDE : LEFT SIDE.

  Patient problems: Limb Fracture

  MAUDE report 11568967 ↗
• InjuryMar 24, 2020Inadequacy of Device Shape and/or Size; Loss of Osseointegration; Inadequacy of Device Shape and/or Size; Loss of Osseointegration

  IT WAS REPORTED THAT THE STEM WAS UNDER SIZED WHICH CAUSED LOOSENING AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2020, DOR: (B)(6) 2020, UNKNOWN AFFECTED SIDE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9872382 ↗
• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PATIENT HAD PAIN, DISABILITY, PHYSICAL IMPAIRMENT, DISFIGUREMENT AND AGGRAVATION OF A PRE-EXISTING CONDITION AFTER ASR HIP IMPLANT. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS 1CM LEG LENGTH DISCREPANCY. DOI: (B)(6) 2006, DOR: (B)(6) 2007, (LEFT HIP).

  Patient problems: Deformity/ Disfigurement; Loss of Range of Motion; No Code Available; Pain

  MAUDE report 9756831 ↗
• InjuryApr 16, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF ALLEGES LOOSENING OF STEM.

  Patient problems: Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 8518773 ↗
• InjuryMar 15, 2019Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS PAIN. UPDATE IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF STEM, METAL WEAR AND METALLOSIS. DOI: (B)(6) 2010 - DOR: (B)(6) 2012 (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8425724 ↗
• InjuryMar 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES ELEVATED METAL IONS AFTER FIRST REVISION. DOI: (B)(6) 2004; DOR: (B)(6) 2012; (LEFT HIP).

  Patient problems: No Code Available; Test Result

  MAUDE report 8404662 ↗
• InjuryFeb 27, 2019Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAINFUL GROIN AREA AND HIP. SURGEONS ORIGINAL PLAN WAS TO REMOVE MOM LINER/ METAL HEAD AND CONVERT TO CERAMIC ON POLY CONSTRUCT. THE AML STEM PRESENTED TO BE LOOSE PROXIMALLY. SURGEON ELECTED TO REMOVE THE STEM AND STEM BROKE AT MID SHAFT LEAVING THE DISTAL 1/2 STILL FIXED IN THE CANAL. AN OSTEOTOMY WAS MADE AND USING A TREPHINE THE DISTAL PORTION WAS CAPTURED. IT WAS ALSO REPORTED THAT THERE WAS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2012, DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Not Applicable; Pain

  MAUDE report 8374361 ↗
• InjuryFeb 12, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  NEW (B)(4) RECORD CREATED IN ORDER TO UPDATE (B)(4) (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT.- LITIGATION ALLEGES THAT PATIENT HAS EXPERIENCED EXTREME PAIN IN RIGHT HIP, LEG AND GROIN; LIMITED MOBILITY; AND DIFFICULTY WALKING WITHOUT A LIMP. UPDATE AD 20 JUN 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF STEM. DOI: (B)(6) 2006 - DOR: (B)(6) 2012 (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 8331145 ↗
• InjuryDec 18, 2018Biocompatibility; Biocompatibility

  LITIGATION ALLEGES PATIENT WAS REVISED TO DUE TO PAIN, DISCOMFORT AND METAL REACTIVE DISEASE. UPDATE AD 3 MAY 2018: RECEIPT OF PPF AND MEDICAL RECORDS. PPF ALLEGED ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PAIN WITH ELEVATED METAL IONS.

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

  MAUDE report 8173310 ↗
• InjuryDec 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2008 - DOR: (B)(6) 2011 (LEFT SIDE). UPDATE 6/12/12 - LITIGATION PAPERS RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. UPDATE AD 14 MAY 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS RECORD. PPF ALLEGES METAL WEAR METALLOSIS AND ELEVATED METAL IONS. ADDED DOB, AGE, LAW FIRM, LAWYER, SURGEON, ACCOUNT NAME, MANUFACTURED AND EXPIRATION DATE IN PRODUCT DETAILS. ADDED STEM DUE TO ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2008 - DOR: (B)(6) 2011 (LEFT HIP).

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

  MAUDE report 8168951 ↗
• InjuryDec 14, 2018Loss of Osseointegration; Loss of Osseointegration

  PPF ALLEGES LOOSENING OF CUP AND LOOSENING OF STEM. DOI: (B)(6) 2006 - DOR: (B)(6) 2007 (RIGHT HIP).

  Patient problems: Inadequate Osseointegration

  MAUDE report 8164016 ↗
• InjuryDec 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN AND POPPING IN BOTH HIPS. UPDATE: RECORDS INDICATED THAT THE PATIENT WAS REVISED ON THE LEFT SIDE BECAUSE OF DISLOCATION ISSUES WITH THE ACETABULAR SHELL RETROVERTED AND VERTICAL. UPDATE: PPF ALLEGES BONE FRACTURE AND ELEVATED METAL IONS. DOI: (B)(6) 2010 - DOR: (B)(6) 2012 (LEFT HIP).

  Patient problems: Joint Dislocation; No Code Available; Pain; Test Result

  MAUDE report 8141889 ↗
• InjuryDec 3, 2018Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION PAPERS ALLEGE: PHYSICAL INJURY, PAIN, BODILY IMPAIRMENT, DEBILITATING LACK OF MOBILITY, HIGH LEVELS OF TOXIC METAL IN HIS BLOOD STREAM, CONSCIOUS PAIN AND SUFFERING AND LOSS OF EARNINGS. UPDATE AD 07 MAY 2018 RECEIPT OF PPF AND MEDICAL RECORDS. IN ADDITION TO PREVIOUS ALLEGATIONS, PPF ALLEGES FRACTURE(BONE), LOOSENING OF STEM AND ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS FAILED RIGHT TOTAL HIP ARTHROPLASTY SECONDARY TO ASEPTIC LOOSENING FEMORAL COMPONENT. REVISION NOTES INDICATED THAT FEMORAL COMPONENT REVEALED NO EVIDENCE OF GROSS LOOSENING ALTHOUGH CERTAINLY SIGNIFICANT OSTEOLYSIS WAS PRESENT THROUGH THE PROXIMAL PORTION OF THE FEMORAL COMPONENT WAS NOTED CIRCUMFERENTIALLY.

  Patient problems: Inadequate Osseointegration; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Osteolysis; Pain; Test Result

  MAUDE report 8124002 ↗
• InjuryNov 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS HIP PAIN. DOI: (B)(6) 2008 - DOR: (B)(6) 2009 (LEFT SIDE). 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 THE THIGH AND HIP AREA, AS WELL AS THE GROIN. PATIENT HAS EXPERIENCED EPISODES OF A GRINDING AND POPPING SENSATION IN THE HIP. DOI: (B)(6) 2008 - DOR: (B)(6) 2009 (LEFT HIP). PATIENT IS A RESIDENT OF (B)(6). UPDATE: 12/20/12 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED FOR PRIMARY SURGERY. RECORDS INDICATE THAT THE PATIENT HAS HAD MULTIPLE SURGERIES, (B)(6) 2010 CLOSED REDUCTION, NOTHING REMOVED; (B)(6) 2010 REVISED FOR INSTABILITY, DEPUY HEAD REMOVED; (B)(6) 2010; (B)(6) 2011. UPDATE AD 01 MAY 2018: (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND STICKER SHEETS. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES METAL WEAR/METALLOSIS. THE EVENT DESCRIPTION HAS BEEN UPDATED TO INDICATE THE ALLEGATI

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

  MAUDE report 8042924 ↗
• InjuryNov 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2007; DOR: NONE REPORTED; (LEFT HIP).

  Patient problems: Discomfort; Inflammation; Pain; Test Result

  MAUDE report 8038166 ↗
• InjuryNov 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2005 -DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Discomfort; Inflammation; Pain; Test Result

  MAUDE report 8038116 ↗
• InjurySep 19, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL STEM AT BONE TO IMPLANT INTERFACE. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; Not Applicable

  MAUDE report 7891299 ↗
• InjuryAug 8, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED DUE TO PAIN AND DISLOCATION. UPDATE AD (B)(6) 2018 (B)(4) IS REOPENED UNDER (B)(4) DUE TO RECEIPT OF PINNACLE LITIGATION RECORDS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, LITIGATION ALLEGES INJURY, ELEVATED BLOOD METAL LEVELS, INJURIES THAT INHIBIT MOVEMENT, EMOTIONAL DISTRESS, AND MENTAL ANGUISH. THE LAWYER, LAW FIRM AND PATIENT HARM HAS BEEN UPDATED. THE STEM WAS INCLUDED DUE TO THE ALLEGED ELEVATED BLOOD METAL LEVELS. DOI: (B)(6) 2007; DOR: (B)(6) 2016; LEFT HIP.

  Patient problems: Distress; Host-Tissue Reaction; Injury; Limited Mobility Of The Implanted Joint; Pain; Test Result

  MAUDE report 7762286 ↗
• MalfunctionJun 18, 2018Corroded; Insufficient Device Problem Information; Corroded; Insufficient Device Problem Information

  AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS FAILED RIGHT TOTAL HIP ARTHROPLASTY. REVISION NOTES REPORTED THAT THERE WAS SOME CORROSION AT THE TAPER.

  Patient problems: Discomfort; Distress; Injury; Limited Mobility Of The Implanted Joint; Not Applicable; Pain; Swelling; Test Result; Tissue Damage; Weakness

  MAUDE report 7609717 ↗