AML 1554-01-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295058229), received between Nov 21, 2017 and Mar 10, 2020 — classified as 19 injuries.

The most frequently reported specific device problem is “Biocompatibility” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS A FAILED METAL-ON-METAL HIP ARTHROPLASTY WITH PAIN AND ELEVATED METAL ION LEVELS. INTRAOPERATIVELY, METALLOSIS DEBRIS WAS PRESENT ALONG WITH CORROSION AND METALLOSIS BEHIND THE POSTERIOR SIDE OF THE INSERT. DOI: (B)(6) 2004; DOR: (B)(6) 2015; RIGHT HIP.

  Patient problems: Foreign Body Reaction; No Code Available; Pain

  MAUDE report 9813538 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT THE PATIENT HAD BILATERAL DEPUY HIP IMPLANTS. NO REVISION REPORTED AND NO ALLEGATION DIRECTED TO LEFT IMPLANTS HOWEVER, PATIENT HAD A LEFT METAL ON METAL CONSTRUCT WITH ELEVATED METAL IONS. DOI: (B)(6) 2008; DOR: NONE REPORTED; LEFT HIP. PLEASE SEE (B)(4) FOR THE RIGHT HIP IMPLANTS.

  Patient problems: No Code Available; Test Result

  MAUDE report 9812712 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF, IMPLANT RECORDS AND STICKER SHEETS RECEIVED. PPF ALLEGES ELEVATED METAL IONS AND DISLOCATION. DOI: (B)(6) 2007 (STEM); DOI: (B)(6) 2014 (LINER & HEAD); DOR: NONE REPORTED RIGHT HIP. SEE (B)(4) RIGHT HIP FIRST REVISION.

  Patient problems: Test Result

  MAUDE report 9168382 ↗
• InjurySep 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT PATIENT EXPERIENCED PAIN, DISCOMFORT, AND INFLAMMATION IN THIGH AND GROIN. PATIENT ALSO EXPERIENCED A POPPING AND SNAPPING SENSATION IN HIP JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES ELEVATED METAL IONS, METAL WEAR, AND METALLOSIS. ADDED STEM DUE TO ALLEGED ELEVATED METAL IONS. DOI: (B)(6) 2007. DOR: (B)(6) 2014, (RIGHT HIP).

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

  MAUDE report 9134027 ↗
• InjuryJun 28, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PATIENT SEEKING LEGAL ACTION. PFS AND MEDICAL RECORDS RECEIVED FROM LEGAL. PFS ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, LIMITED MOBILITY, AND CLICKING. REVISION OPERATIVE NOTES INDICATE THAT THE FEMORAL COMPONENT WAS 'GROSSLY LOOSE'. DOI: (B)(6) 2008, DOR: (B)(6) 2009, (RIGHT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; No Code Available; Pain; Test Result

  MAUDE report 8744446 ↗
• InjuryMar 19, 2019Fracture; Loose or Intermittent Connection; Fracture; Loose or Intermittent Connection

  THE PATIENT REVISED DUE TO A BROKEN AML STEM. THE STEM WAS REMOVED AND A NEW STEM AND POLY AND HEAD IMPLANTED. THERE WAS ALSO LOOSENING OF FEMORAL STEM AT BONE TO IMPLANT INTERFACE. DOI: 2005; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8432982 ↗
• InjuryFeb 13, 2019Adverse 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: (B)(6) 2010; (RIGHT HIP).

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

  MAUDE report 8335495 ↗
• InjuryJan 7, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PATIENT ALLEGES PAIN, STIFFNESS/WEAKNESS, LIMITED MOBILITY, A GRINDING SENSATION, AND ELEVATED COBALT CHROMIUM LEVELS. DOI: (B)(6) 2006 - DOR: NOT REPORTED (LEFT HIP).

  Patient problems: Discomfort; Fatigue; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Metal Related Pathology; Muscular Rigidity; Pain; Test Result; Weakness

  MAUDE report 8221618 ↗
• InjuryJan 2, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES FRACTURE BONE, METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS BEFORE THE FIRST REVISION. DOI: (B)(6) 2008, DOR: (B)(60 2016 (LEFT HIP) FIRST REVISION.

  Patient problems: Pain; Test Result; Tissue Damage

  MAUDE report 8207791 ↗
• InjuryDec 18, 2018Biocompatibility; Biocompatibility

  PATIENT WAS REVISED TO ADDRESS A METAL ON METAL REACTION. DOI: 2004 - (B)(6) 2011 (LEFT HIP). PATIENT COMPENSATION REQUEST. UPDATE - 05/04/2012 - MEDICAL RECORDS RECEIVED. DOI IS STATED AS (B)(6) 2004. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. COMPLAINT AND MDRS UPDATED. MEDICAL RECORDS ATTACHED TO ETQ RECORD. UPDATE: 12/26/12 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE 3/1/2013 - LITIGATION PAPERS RECEIVED. IT IS ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, SWELLING, BURSITIS, LACK OF MOBILITY, AND/OR METALLOSIS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. UPDATE AD 29 JUNE 2018: (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND STICKER SHEETS RECORD. IN ADDITION TO PREVIOUS ALLEGATIONS, PPF ALLEGES ABDUCTOR MUSCLE REPAIR, METAL WEAR/METALLOSIS AND ELEVATED METAL IONS. ADDED STEM DUE TO ALLEGED ELEVATED METAL IONS. ADDED LAWYER, LAW FIRM, REVISION SURGEON, REVISION HOSPITAL AND EXPIRATION DATE OF IMPACTED PRODUCTS. UPDATED PATIENT'S INITIALS AND CORRECTED PATIENT'S DOB. DOI: (B)(6) 2004 -

  Patient problems: Limited Mobility Of The Implanted Joint; Pain; Swelling; Test Result; Tissue Damage

  MAUDE report 8173568 ↗
• InjuryDec 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN AND OSTEOLYSIS. LITIGATION PAPERS RECEIVED. THEY MENTION THAT NECROTIC MATERIAL AND AN INFLAMED SYNOVIUM WERE DISCOVERED AT THE TIME OF REVISION. NO MENTION OF OSTEOLYSIS IN THE REVISION OPERATIVE NOTE. IN ADDITION TO PREVIOUS ALLEGATIONS, PPF ALLEGES PSEUDOTUMOR, METAL WEAR/METALLOSIS, ABDUCTOR MUSCLE REPAIR AND ELEVATED METAL IONS. DOI: (B)(6) 2008 - DOR: (B)(6) 2011 (LEFT HIP).

  Patient problems: Inflammation; Necrosis; Pain; Test Result; Tissue Damage

  MAUDE report 8169562 ↗
• InjuryDec 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES ELEVATED METAL IONS.

  Patient problems: Test Result

  MAUDE report 8134922 ↗
• InjuryNov 29, 2018Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  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.. PATIENT HAS EXPERIENCED EPISODES OF A GRINDING AND POPPING SENSATION IN HER RIGHT HIP. UPDATE AD 01 MAY 2018 RECEIPT OF PPF AND STICKER SHEETS RECORD.

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

  MAUDE report 8115166 ↗
• InjuryNov 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS IT WAS NOTED THAT THE PATIENT HAD A PROSTALAC HIP IMPLANTATION STATUS POST DEBRIDEMENT FOR INFECTION ON (B)(6) 2009.

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

  MAUDE report 8084328 ↗
• InjuryNov 19, 2018Loose or Intermittent Connection; Osseointegration Problem; Migration; Loose or Intermittent Connection; Osseointegration Problem; Migration

  LITIGATION ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2006 - DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Inadequate Osseointegration; Pain; Test Result; Weakness

  MAUDE report 8084247 ↗
• InjuryOct 23, 2018Collapse; Collapse

  REVISION DUE TO SUBSIDENCE OF THE FEMORAL STEM.

  Patient problems: No Code Available

  MAUDE report 7995405 ↗
• InjuryOct 9, 2018Biocompatibility; Biocompatibility

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. UPDATE AD 1 MAY 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND STICKER SHEETS. THERE ARE NEW INDICATIONS THAT THE PATIENT IS BILATERAL, WHICH IS WHY THIS COMPLAINT WAS CREATED FOR THE RIGHT HIP. THERE ARE NO ALLEGATIONS OR REVISION REPORTED. DOI: (B)(6) 2007; DOR: NONE REPORTED; (RIGHT HIP). (B)(4) FOR LEFT HIP.

  Patient problems: Test Result

  MAUDE report 7946446 ↗
• InjuryOct 5, 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

  LITIGATION ALLEGES PAIN, DISCOMFORT, INFLAMMATION, SWELLING, DIFFICULTY AMBULATING, DIFFICULTY WEIGHT BEARING, AND ADDED STEM DUE TO ALLEGED ELEVATED METAL IONS.

  Patient problems: Discomfort; Inflammation; Pain; Swelling; Test Result

  MAUDE report 7938026 ↗
• InjuryNov 21, 2017Naturally Worn; Appropriate Device Problem Term/Code Not Available; Naturally Worn; Appropriate Device Problem Term/Code Not Available

  COMPLAINT DESCRIPTION: AUG 9, 2017: LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES DEFECTIVE DEVICE, PHYSICAL AND MENTAL PAIN AND DEBILITY. UPDATE NOV 6, 2017: PFS AND MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PFS ALLEGES DIFFICULTY IN MOBILITY AND ELEVATED METAL LEVELS. AFTER REVIEW OF MEDICAL RECORDS FOR THE MDR REPORTABILITY, IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN. REVISION NOTES REPORTED ELEVATED METAL LEVELS, OSTEOLYSIS, METAL LINE PSEUDOCAPSULE, METAL DEBRIS INSIDE THE LINER AND THE TRUNNION OF THE FEMORAL NECK, AND WEAKNESS. PART/LOT INFORMATION WERE PROVIDED. THIS COMPLAINT WAS UPDATED ON NOV 10, 2017.

  Patient problems: Ambulation or Postural Difficulties; Not Applicable; Osteolysis; Pain; Tissue Damage

  MAUDE report 7048989 ↗