AML 1554-01-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295058205), received between Aug 10, 2017 and Jan 12, 2021 — classified as 17 injuries.

The most frequently reported specific device problem is “Fracture” (4 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2021Fracture; Fracture

  REMOVAL OF A BROKEN 10.5 AML STEM FROM A PATIENT, THE STEM BROKE HALFWAY DOWN THE SHAFT. THE PATIENT DID NOT FRACTURE HER LEG IT WAS A DEVICE MANUFACTURING FAILURE, IT WAS REMOVED FROM THE PATIENT AND REVISED. THERE WAS AN ASR IMPLANT IN THE PATIENT THAT THE HEAD AND TAPER WAS ALSO REMOVED. THE TAPER WAS COLDWELDED INTO THE PATIENT AND IT COULD NOT BE TAKEN OUT AND UNABLE TO READ SERIAL OR LOT NUMBER.

  Patient problems: Ambulation or Postural Difficulties; Fall; Pain

  MAUDE report 11155395 ↗
• InjuryJan 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES THAT THE PATIENT EXPERIENCED SEVERE PAIN AND DISCOMFORT, SUFFERING, INJURY, EMOTIONAL DISTRESS, DISABILITY, DISFIGUREMENT, PARTIAL OR COMPLETE LOSS OF MOBILITY AND LOSS OF RANGE OF MOTION. DOI: (B)(6) 2008; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Anxiety; Deformity/ Disfigurement; Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Injury; Limited Mobility Of The Implanted Joint; Necrosis; No Code Available; Pain; Test Result

  MAUDE report 9637569 ↗
• InjuryJan 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES THAT THE PATIENT EXPERIENCED SEVERE PAIN AND DISCOMFORT, SUFFERING, INJURY, EMOTIONAL DISTRESS, DISABILITY, DISFIGUREMENT, PARTIAL OR COMPLETE LOSS OF MOBILITY AND LOSS OF RANGE OF MOTION. DOI: (B)(6) 2007; DOR: NOT INDICATED; RIGHT HIP.

  Patient problems: Anxiety; Deformity/ Disfigurement; Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Injury; Limited Mobility Of The Implanted Joint; Necrosis; No Code Available; Pain; Test Result

  MAUDE report 9637536 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED FOR PAIN. UPDATE AD 13 SEP 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF AND IMPLANT RECORDS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2007 - DOR: (B)(6) 2015 (LEFT HIP) FIRST REVISION.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; No Code Available; Pain; Test Result

  MAUDE report 9008407 ↗
• InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ASR PLAINTIFF FACT SHEET RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS FAILURE OF THE RIGHT TOTAL HIP REPLACEMENT SECONDARY TO METAL-ON-METAL COMPONENTS. THE PATIENT HAD BEEN EXPERIENCING PAIN PRIOR TO BEING REVISED. INFECTION WAS RULED OUT. IT WAS NOTED THAT THE PATIENT HAD ELEVATED LABS INDICATING METAL-ON-METAL TOXICITY. OPERATIVE FINDINGS INCLUDE A PSEUDOTUMOR WITH A LARGE AMOUNT OF FLUID AND NECROTIC TISSUE. THERE WAS NO LOOSENING ON THE STEM. DOI: (B)(6) 2007 - DOR: (B)(6) 2017 (RIGHT HIP).

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Distress; Foreign Body Reaction; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result; Weakness

  MAUDE report 8802655 ↗
• InjuryJul 9, 2019Fracture; Fracture

  PPF AND STICKER SHEETS RECORD RECEIVED. PPF ALLEGES INFECTION, COMPONENT FRACTURE AND DISLOCATION WITH CLOSED REDUCTION AFTER FIRST REVISION. DOI: (B)(6) 2007 (STEM, CUP AND HOLE ELIMINATOR). DOI: (B)(6) 2008 (HEAD AND LINER). DOR: (B)(6) 2012 (RIGHT HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8771410 ↗
• InjuryJul 9, 2019Fracture; Fracture

  PPF AND STICKER SHEETS RECORD RECEIVED. PPF ALLEGES INFECTION, COMPONENT FRACTURE AND DISLOCATION WITH CLOSED REDUCTION AFTER FIRST REVISION. DOI: (B)(6) 2007, (STEM, CUP AND HOLE ELIMINATOR); DOI: (B)(6) 2010, (HEAD AND LINER); DOR: NONE REPORTED, (LEFT HIP).

  Patient problems: Unspecified Infection

  MAUDE report 8771330 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INSTABILITY. AFTER REVIEW OF THE REVISION OPERATIVE NOTE IT INDICATED METALLOSIS. THE COMPLAINT WAS UPDATED ON: 05/20/2014 IN ADDITION TO PREVIOUS ALLEGATIONS, PPF ALLEGES ELEVATED METAL IONS. ADDED STEM DUE TO ALLEGED ELEVATED METAL IONS. DOI: (B)(6) 2005 - DOR: (B)(6) 2013 (LEFT HIP).

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

  MAUDE report 8757507 ↗
• InjuryMar 28, 2019Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. PFS HAS NO ALLEGATION. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISE ON (B)(6) 2014 DUE TO PAIN, CATASTROPHICALLY FAILED LEFT TOTAL HIP ARTHROPLASTY WITH FRACTURE OF THE FEMORAL COMPONENT WITHOUT FRACTURE OF THE BONE. OPERATIVE NOTES REPORTED FEMORAL COMPONENT WAS NOTED TO BE GROSSLY LOOSE IN THE PROXIMAL PORTION CORRESPONDING TO THE FRACTURE OF THE FEMORAL STEM. DOI: (B)(6) 2007; DOR: (B)(6) 2014; LEFT HIP.

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

  MAUDE report 8458972 ↗
• InjuryMar 11, 2019Biocompatibility; Biocompatibility

  LITIGATION ALLEGES THAT PATIENT EXPERIENCED SEVERE AND CONSTANT PAIN AND SUFFERING, SWELLING, BURSITIS, LACK OF MOBILITY AND/OR METALLOSIS. UPDATE AD 12 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 METAL WEAR AND ELEVATED METAL IONS.

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

  MAUDE report 8407823 ↗
• InjuryFeb 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CORRECTED PATIENT HARM. SOFT TISSUE INJURY WAS CHANGED TO FOREIGN BODY REACTION.

  Patient problems: Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; No Code Available; Pain; Test Result; Tissue Damage

  MAUDE report 8320747 ↗
• InjuryJan 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION AFTER FIRST REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8250858 ↗
• InjuryDec 21, 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 SUFFERING. PPF ALLEGES PSEUDOTUMOR, METALLOSIS, METAL WEAR AND ELEVATED METAL IONS BEFORE FIRST REVISION. DOI: (B)(6) 2005; DOR: (B)(6) 2013; (LEFT HIP).

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

  MAUDE report 8189167 ↗
• InjuryDec 13, 2018Biocompatibility; Biocompatibility

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

  Patient problems: Test Result

  MAUDE report 8159380 ↗
• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6) 2007, PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE MOM HIP IMPLANT ON HER RIGHT SIDE. THE IMPLANT HAS CAUSED METAL IONS AND PARTICLES TO BE RELEASED INTO HER BLOOD, TISSUE, AND BONE SURROUNDING THE IMPLANT. SHE HAS ALSO BEEN EXPERIENCING SEVERE PAIN, DISCOMFORT AND INFLAMMATION IN HER RIGHT THIGH AND GROIN, AS WELL AS A POPPING AND SNAPPING SENSATION IN HER HIP JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. PATIENT WILL LIKELY NEED TO UNDERGO REVISION SURGERY. DOI: (B)(6) 2007; DOR: NONE REPORTED; (RIGHT HIP).

  Patient problems: Discomfort; Inflammation; Pain; Test Result

  MAUDE report 8045711 ↗
• InjuryOct 22, 2018Biocompatibility; Biocompatibility

  LITIGATION PAPERS ALLEGE AFTER PATIENT'S SURGERY, FRICTION AND WEAR BETWEEN THE COBALT-CHROMIUM METAL HEAD AND COBALT-CHROMIUM LINER CAUSED LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PATIENT'S BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. IT IS ALSO ALLEGED AS A RESULT, PATIENT HAS BEEN EXPERIENCING SEVERE PAIN AND DISCOMFORT AND INFLAMMATION IN HER RIGHT THIGH AND GROIN. IT IS FURTHER ALLEGED PATIENT ALSO EXPERIENCES A POPPING AND SNAPPING SENSATION IN HER HIP-JOINT WHEN WALKING OR MOVING TO AND FROM A SITTING POSITION. UPDATE 01 MAY 2018: PPF AND STICKER SHEETS. PPF HAS NO NEW ALLEGATIONS REPORTED. UPDATED THE PRODUCT INFORMATION OF THE LINER. ADDED DATE OF BIRTH, LAWYER AND LAW FIRM IN THE FACILITY NAME. AN IMPACTED PRODUCT RECORD FOR THE HEAD AND STEM WAS ADDED DUE TO PREVIOUSLY ALLEGED ELEVATED METAL ION LEVEL

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

  MAUDE report 7991510 ↗
• InjuryAug 10, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  LITIGATION ALLEGES PATIENT WAS REVISED DUE TO PAIN, METALLOSIS AND AVASCULAR NECROSIS. UPDATE JUL 12, 2017: LEGAL MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PFS ALLEGES LOSS OF BALANCE, DIFFICULTY SITTING/STANDING, STIFFNESS, AND HIGH LEVELS OF COBALT-CHROMIUM. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS STATED THAT THE PATIENT WAS REVISED DUE TO INFECTED LEFT THA. REVISION NOTE STATED GROSS PUS, CHRONIC NON-DISPLACED FRACTURE OF THE GREATER TROCHANTER. LABORATORY VALUES FOR COBALT-CHROMIUM SHOWED ABOVE 7PPB. CUP, TWO SCREWS, STEM, AND HOLE ELIMINATOR WERE ADDED DUE TO THE REPORTED INFECTION. PART AND LOT INFORMATION WERE PROVIDED. THIS COMPLAINT WAS UPDATED ON: AUG 7, 2017.

  Patient problems: Bone Fracture(s); Foreign Body Reaction; Muscular Rigidity; Necrosis; Pain; Unspecified Infection

  MAUDE report 6785039 ↗