AML 1554-01-106Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295058212), received between Jan 28, 2016 and Apr 9, 2020 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORD, PATIENT WAS REVISED TO ADDRESS FAILED WORN METAL ON METAL ACETABULAR COMPONENT WITH METALLOSIS. REVISION NOTES STATED THAT BURSA AND METAL DEBRIS WERE REMOVED. PATIENT EXPERIENCED DISLOCATION, PAIN, AND HAVE ELEVATED METAL ION LEVEL. DOI: (B)(6) 2010; DOR: (B)(6) 2019 (RIGHT HIP).

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

  MAUDE report 9943502 ↗
• InjuryMar 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORD RECEIVED. AFTER REVIEW OF MEDICAL RECORD, THE PATIENT WAS REVISED TO ADDRESS MECHANICAL COMPLICATION OF INTERNAL RIGHT HIP. THE PATIENT BEGAN DEVELOPING PAIN, SENSATION OF CLUNKING IN THE HIP AND ELEVATED METAL ION. REVISION NOTE REPORTED SOME METALLOSIS DEBRIS AROUND THE CAPSULAR TISSUE OF THE HIP. DOI: (B)(6) 2010; DOR: (B)(6) 2017; (RIGHT HIP).

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

  MAUDE report 9799547 ↗
• InjuryJan 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PERIPROSTETIC FEMUR FRACTURE THAT REQUIRED INTERNAL FIXATION. DOI: (B)(6) 2018; DOR: (B)(6) 2019; UNKNOWN AFFECTED SIDE.

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

  MAUDE report 9582113 ↗
• InjurySep 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND DIFFICULTY AMBULATING. UPDATE RECEIVED (B)(6) 2014: THE COMPLAINT HAS BEEN UPDATED BECAUSE IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED ON (B)(6) 2014 DUE TO SIGNIFICANT METALLOSIS, BLACKENING OF TISSUE, PAIN, AND LOOSENING OF THE CUP. UPDATE AD (B)(6) 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF, STICKER SHEETS, AND IMPLANT RECORDS. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR, METAL WEAR, AND ELEVATED METAL IONS. ADDED STEM DUE TO ELEVATED METAL IONS. DOI: (B)(6) 2010, DOR: (B)(6) 2014 (LEFT HIP).

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

  MAUDE report 8977267 ↗
• InjuryNov 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2007 - DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Discomfort; Pain; Test Result

  MAUDE report 8055161 ↗
• InjuryNov 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES METALLOSIS, AND ELEVATED METAL IONS. DOI: (B)(6) 2007 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Discomfort; Pain; Test Result

  MAUDE report 8055067 ↗
• InjuryOct 30, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE STEM APPEARED TO BE BROKEN ON X-RAY.

  Patient problems: No Code Available

  MAUDE report 8019944 ↗
• InjuryMay 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PPF AND IMPLANT RECORDS RECEIVED. PINNACLE PLAINTIFF PROFILE FORM ALLEGES PULMONARY EMBOLISM AFTER FIRST REVISION. DOI CUP, SCREWS, AND STEM: (B)(6) 2009; DOI LINER AND HEAD: (B)(6) 2014; DOR ALL PRODUCTS: NONE; LEFT HIP.

  Patient problems: Pulmonary Embolism

  MAUDE report 7540094 ↗
• InjuryOct 10, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  DER STATES THAT THE FEMORAL STEM WAS PERFORATED THROUGH THE POSTERIOR FEMORAL CORTEX..

  Patient problems: Bone Fracture(s)

  MAUDE report 6938011 ↗
• InjurySep 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT PATIENT HAD SCIATIC PALSY AFTER ORIGINAL SURGERY, POSSIBLY DUE TO MANIPULATION DURING ORIGINAL SURGERY. THE SURGEON PLANS TO SHORTEN THE NECK LENGTH HOPING THAT SCIATIC NERVE WILL REGENERATE. UPDATE 8-25-2017: MEDICAL RECORDS HAVE BEEN REVIEWED. PROGRESS NOTES (B)(6) 2017 INDICATE THE PATIENT IS SUFFERING FROM OSTEOARTHRITIS FROM LEFT HIP DYSPLASIA, CONGENITAL DYSPLASIA. REPORTABILITY REMAINS THE SAME. UPDATED 9-11-2017.

  Patient problems: Nerve Damage

  MAUDE report 6855571 ↗
• InjuryJan 28, 2016Adverse 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 PAPERS ALLEGE THE PATIENT SUSTAINED SERIOUS PERSONAL INJURIES AS A RESULT OF THE HIP FAILING, BREAKING APART, CAUSING DANGEROUS METALS TO BE RELEASED INTO HER BODY AND BLOOD SYSTEM AND CAUSING SERIOUS PERSONAL INJURIES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Hypersensitivity/Allergic reaction; No Code Available; Pain; Scar Tissue

  MAUDE report 5396373 ↗