AML 1554-02-165Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295058380), received between Jun 29, 2017 and May 3, 2022 — classified as 13 injuries, 1 malfunction.

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FRACTURE. THERE IS NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2004. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Limb Fracture

  MAUDE report 14269336 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PAIN, LOSS OF BALANCE, DIZZINESS, DIFFICULTY WALKING, STOMACH UPSET, DETERIORATION AND FAILURE OF THE PRODUCT, ELEVATED METAL IONS, ABRASION OF THE METAL ON METAL COMPONENTS WITH THE BEARING CAUSING METAL DEBRIS IN THE BODY, TISSUE DEHISCENCE, NECROSIS, HYPERTROPHIC SCARRING, ANTALGIA, LUMBAR STRAIN, FATIGUE, LIMITED ADL AND EMOTIONAL DISTRESS. DOI: (B)(6) 2011; DOR: (B)(6) 2020; UNKNOWN HIP.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Dizziness; Fatigue; Foreign Body Reaction; Loss of Range of Motion; Necrosis; Pain; Scar Tissue; Wound Dehiscence

  MAUDE report 12631211 ↗
• InjuryJun 16, 2021Inadequacy of Device Shape and/or Size; Osseointegration Problem; Migration; Inadequacy of Device Shape and/or Size; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LOT OF PAIN. STEM SUBSIDED, SURGEON BELIEVED IT TO BE INFECTED BUT IT WAS NOT. STEM LOOKED UNDERSIZED ON ORIGINAL XRAY. LINER SWAPPED AND LARGER STEM IMPLANTED WITH NEW HEAD. ORIGINAL SIZE WAS 16.5 LG, IMPLANTED A 19.5 LG. IT WAS ALSO INDICATED THAT THERE WAS LOOSENING OF THE STEM AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2018; DOR: (B)(6) 2021; AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12010164 ↗
• InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DISTAL TIP OF AML STEM WAS STICKING OUT OF THE POST. CORTEX. DOI: (B)(6) 2020, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Bone Fracture(s)

  MAUDE report 11286226 ↗
• InjuryMar 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLEGES METAL WEAR/METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2009 - DOR: NOT REPORTED (LEFT HIP).

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

  MAUDE report 8436794 ↗
• InjuryFeb 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: LITIGATION ALLEGES PAIN AND DIFFICULTY AMBULATING. IT IS FURTHER ALLEGED THAT PATIENT OCCASIONALLY DEVELOPS A RASH ON THE LEFT SIDE AND OFTEN HAS A STRANGE TASTE IN HIS MOUTH. UPDATE PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2010; DOR: (B)(6) 2014; (LEFT HIP).

  Patient problems: No Code Available; Pain; Test Result

  MAUDE report 8347763 ↗
• InjuryFeb 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2010; DOR: (B)(6) 2011; (RIGHT HIP).

  Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Test Result; Tissue Damage

  MAUDE report 8331437 ↗
• InjuryJan 28, 2019Biocompatibility; Biocompatibility

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT. -PATIENT WAS REVISED DUE TO INFECTION. DOI: 2005 - DOR: (B)(6) 2011 (RIGHT HIP). UPDATE 11/7/2012- LITIGATION PAPERS RECEIVED. IN ADDITION TO INFECTION, IT IS NOW ALLEGED THAT THE PATIENT SUFFERS FROM PAIN AND ELEVATED LEVELS OF COBALT CHROMIUM. THE MDR DECISION HAS BEEN REVERSED AND INITIAL EMDRS CREATED. UPDATE 3/27/2013- PFS RECEIVED FROM LEGAL. THE CORRECT DOI AND DOR WERE PROVIDED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. DOI: (B)(6) 2005- DOR: (B)(6) 2011, (SPACER), DOR: (B)(6) 2011, (RIGHT HIP). UPDATE: 8/20/13 - ADDITIONAL LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, IT IS NOW ALLEGED THAT THE PATIENT SUFFERS FROM SWELLING AND METALLOSIS. LITIGATION ALSO ALLEGES THAT PATIENT HAD PURULENT MATERIAL IN THE HIP, AS WELL AS A LARGE ABSCESS. THE HOLE ELIMINATOR AND ACETABULAR CUP SHOULD HAVE BEEN REPORTED WHEN LITIGATION WAS ORIGINALLY RECEIVED, HOWEVER, THERE WAS AN OVERSIGHT. THE HOLE ELIMINATOR AND CUP ARE NOW BEING REPORTED. UPDATE AD 12 JUN 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE R

  Patient problems: Pain; Swelling; Test Result; Tissue Damage; Unspecified Infection

  MAUDE report 8281007 ↗
• InjuryJan 10, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS HIP PAIN. UPDATE AD 25 JUN 2018 RECEIPT OF PPF AND STICKER SHEETS. PPF ALLEGES DISLOCATION, METAL WEAR AND METALLOSIS AND ELEVATED METAL IONS.

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

  MAUDE report 8235441 ↗
• InjuryDec 20, 2018Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS. DOI: (B)(6) 2009 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Test Result; Tissue Damage

  MAUDE report 8184010 ↗
• InjuryNov 13, 2018Biocompatibility; Biocompatibility

  PATIENT WAS REVISED BECAUSE SHE DISLOCATED IN 2009 AND HAS HAD PAIN EVER SINCE. UPDATE 9/9/2011 - LITIGATION PAPERS WERE RECEIVED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE 12/31/2014- PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY UPDATE AD 01 MAY 2018: RECEIPT OF PPF AND STICKER SHEETS RECORD. PPF ALLEGES ELEVATED METAL IONS. ADDED LAW FIRM, ASSOCIATED CONTACT,ACCOUNT NAME, PRODUCT DETAILS IN ALL IPS. ADDED STEM DUE TO ALLEGED METAL IONS.

  Patient problems: No Code Available; Pain; Test Result

  MAUDE report 8063901 ↗
• MalfunctionNov 9, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE PLASTIC BUBBLE WAS BROKEN AND IS COMPROMISING THE STERILITY OF THE IMPLANT.

  Patient problems: Not Applicable

  MAUDE report 8054628 ↗
• InjuryOct 17, 2018Biocompatibility; Biocompatibility

  LITIGATION ALLEGES PAIN AND DISCOMFORT. UPDATE AD 21 SEP 2018 IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, LITIGATION ALLEGES METALLOSIS, MENTAL ANGUISH, SUFFERING, EMOTIONAL DISTRESS, INJURY, PAINFUL INFECTION, AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN THE BLOOD.

  Patient problems: Discomfort; Foreign Body Reaction; Injury; Pain; Test Result; Tissue Damage; Unspecified Infection

  MAUDE report 7975259 ↗
• InjuryJun 29, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  COMPLAINT DESCRIPTION: LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT AND TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE AND BONE. UPDATE REC'D (B)(6) 2014 - SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS PAIN. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THE COMPLAINT WAS UPDATED ON: (B)(6) 2014. UPDATE (B)(6) 2017: LEGAL MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PFS ALLEGES DECREASED ACTIVITY LEVEL, COULD NOT WALK LONG DISTANCES AND WAS UNABLE TO SLEEP ON THE LEFT SIDE, AND ELEVATED CHROMIUM-COBALT LEVELS. AFTER REVIEW OF THE MEDICAL RECORDS FOR THE MDR REPORTABILITY, IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS PAINFUL METAL-ON-METAL LEFT THA. REVISION NOTES STATED THAT THE GRANULATION TISSUE PRESENT IN THE ANTERIOR CAPSULE DID NOT HAVE A DARK BLACK APPEARANCE AND SEEMED MORE OF A CHRONIC SYNOVITIS. THERE WAS NO EVIDENCE OF SIGNIFICANT METALLOSIS. THE CUP AND HEAD WAS NOTED TO HAVE ABRASIONS SECONDARY TO THE REMOVAL PROCESS. THE TRUNNION OF THE STEM APPEARED TO BE IN GOOD CONDITION WITH NO CORROSION. DISCHARGE NOTES STATED THAT THERE WAS SOME HETEROTOPIC

  Patient problems: Discomfort; Inflammation; Pain; Tissue Damage

  MAUDE report 6677206 ↗