AML 1554-01-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295058250), received between Dec 12, 2017 and Oct 26, 2022 — classified as 15 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE UNSTABLE STEM AND POSSIBLE INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 15672752 ↗
• InjuryJun 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT WAS LAST SEEN ON (B)(6) 2019 AND STATED THAT HANDS AND LEGS BUCKLE WHEN WALKING. BY BUCKLE MEANS LEGS ARE WEAK. WEAKNESS OF BOTH LOWER EXTREMITIES, GAIT ABNORMALITY, AND WEIGHT LOSS.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Bone Fracture(s); Calcium Deposits/Calcification; Extraskeletal ossification; Fall; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Inflammation; Injury; No Code Available; Pain; Weakness

  MAUDE report 10135712 ↗
• InjuryMar 24, 2020Corroded; Degraded; Corroded; Degraded

  AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESS UNSTABLE REVISION, RIGHT TOTAL HIP, WITH MRI DIAGNOSIS OF COMPLETE EVULSION OF HIP GIRDLE MUSCULATURE. REVISION NOTES REPORTED THAT SHE HAS DISLOCATED HER HIP TWICE. MRI PREOP TO THIS SURGERY SHOWED THAT SHE HAD NO CONNECTION OF HER MUSCULATURE TO THE GREATER TROCHANTER AND, THEREFORE, BECAUSE OF HISTORY OF DISLOCATION AND THE NEED FOR A HIP ABDUCTOR BRACE 24 HOURS A DAY, IT WAS DECIDED SHE SHOULD HAVE CONVERSION TO A CONSTRAINED LINER IN HER ACETABULUM AND RE-REPAIR OF HER ABDUCTOR MUSCULATURES. PATIENT'S HISTORY OF ILLNESS REPORTED THAT SHE HAS CORROSION BETWEEN HER TRUNNION IN HER FEMORAL HEAD CAUSING LOTS OF IRRITATION FROM METAL DEBRIS AND FLUID SECRETION AROUND THE HIP. DOI: (B)(6) 2016. DOR: (B)(6) 2017; (RIGHT HIP). PLEASE SEE (B)(4) FOR THE 1ST REVISION.

  Patient problems: Edema; No Code Available; Skin Irritation; Tissue Damage

  MAUDE report 9871672 ↗
• InjuryJan 10, 2020Loss of Osseointegration; Osseointegration Problem; Migration; Loss of Osseointegration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE PATIENT HAS A RIGHT TOTAL HIP WITH AML STEM AND PINNACLE CUP. THE STEM HAS SUBSIDED AND WAS LOOSEN AT BONE TO IMPLANT INTERFACE. THE SURGEON REMOVED THE STEM AND CHANGED THE LINER OF THE CUP. THE CUP WAS WELL FIXED AND RETAINED. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9578276 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECEIVED. LITIGATION ALLEGES PAIN AND DISCOMFORT. PLAINTIFF HAS NOT HAD IMPLANT EXPLANTED AS OF THIS DATE. UPDATE 17 JUL 2017: MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PFS ALLEGES DIFFICULTY WALKING AND DOING DAILY ACTIVITIES. AFTER REVIEW OF MEDICAL RECORDS, THERE IS NO NEW INFORMATION. THIS COMPLAINT WAS UPDATED ON: AUG 8, 2017. UPDATE 13 APR 2018: (B)(4) IS A RE-OPEN OF (B)(4) DUE TO THE RECEIPT OF PINNACLE PPF AND MEDICAL RECORDS. PPF HAS NO NEW ALLEGATION. AFTER THE REVIEW OF MEDICAL RECORDS, THERE IS NO NEW INFORMATION ADDED THAT WILL CHANGE THE MDR REPORTABILITY. ONCE NEW INFORMATION IS RECEIVED THIS COMPLAINT WILL BE UPDATED. DOI: (B)(4) 2008; DOR: NOT REVISED; RIGHT HIP.

  Patient problems: Discomfort; Hypersensitivity/Allergic reaction; No Code Available; Pain; Test Result

  MAUDE report 9570777 ↗
• InjuryOct 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: THE PATIENT WAS REVISED TO ADDRESS PAIN. UPDATE AD 05 SEP 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 CUP, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2006; - DOR: (B)(6) 2016; (RIGHT HIP). PATIENT IS BILATERAL, PLEASE SEE (B)(4) FOR THE LEFT HIP.

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

  MAUDE report 9213399 ↗
• InjurySep 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT: LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM SEVERE PAIN, DISCOMFORT, INFLAMMATION, DISLOCATION, DISARTICULATION, A SLIPPING FEELING, CRUNCHING/POPPING NOISES, FRACTURES, INFECTION, NECROSIS, CORROSION AND/OR METALLOSIS. UPDATE AD 1 NOV 2018: (B)(4) HAS BEEN REOPENED UNDER (B)(4) DUE TO THE RECEIPT OF PPF. PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2008. DOR: (B)(6) 2015. (LEFT HIP).

  Patient problems: Foreign Body Reaction; Inflammation; Necrosis; No Code Available; Pain; Test Result; Unspecified Infection

  MAUDE report 9032222 ↗
• InjurySep 4, 2019Fracture; Fracture

  REVISION SURGERY WAS PERFORMED ON A (B)(6) YEAR OLD AML FEMORAL STEM THAT HAD FRACTURED IN THE PAST COUPLE MONTHS. FRACTURE OCCURRED AT THE BEGINNING OF PARALLEL GEOMETRY. ALL PIECES RECOVERED, SURGERY SUCCESSFULLY COMPLETELY. WILL RETURN IF HOSPITAL RELEASES. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? YES, IF YES, PLEASE DESCRIBE. STEM FRACTURED IN TWO, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES, WAS DEVICE EXPLANTED? TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: FRACTURE, DID PATIENT REQUIRE REVISION SURGERY? TRUE, REASON FOR REVISION SURGERY. IMPLANT FRACTURE, PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES.

  Patient problems: No Code Available; Pain

  MAUDE report 8958801 ↗
• InjuryApr 11, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  LITIGATION ALLEGES THE PATIENT SUFFERS FROM FRICTION AND WEAR CAUSING LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PATIENT'S BLOOD, TISSUE AND BONE; PAIN; DISCOMFORT; AND INFLAMMATION. UPDATE IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF STEM. DOI: (B)(6) 2010 - DOR: NONE REPORTED (LEFT HIP).

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; Pain; Test Result

  MAUDE report 8505738 ↗
• InjuryApr 9, 2019No Apparent Adverse Event; No Apparent Adverse Event

  PPF ALLEGES BONE FRACTURE. THE CUP INVOLVED IS A NON DEPUY PRODUCT.

  Patient problems: Bone Fracture(s)

  MAUDE report 8497171 ↗
• InjuryApr 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGE METAL WEAR AND METALLOSIS. DOI: (B)(6) 2007 CUP AND STEM - DOI: (B)(6) 2011 HEAD AND LINER DOR: (B)(6) 2011 (RIGHT HIP).

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 8490798 ↗
• InjuryFeb 21, 2019Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN AND DISCOMFORT. GENERAL LITIGATION ALLEGES METAL ON METAL IMPLICATIONS. UPDATE AD 05 SEP 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 INFECTION, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS.

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

  MAUDE report 8357435 ↗
• InjuryDec 10, 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 PPF ALLEGES BONE FRACTURE, DISLOCATION AND ELEVATED METAL IONS. DOI: (B)(6) 2011, DOR: NOT REPORTED, (RIGHT HIP).

  Patient problems: Pain; Test Result

  MAUDE report 8145973 ↗
• InjuryJul 19, 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

  COMPLAINT DESCRIPTION: LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, DIFFICULTY AMBULATING, FLUID COLLECTION AND TOXIC COBALT-CHROMIUM METAL DEBRIS TO BE RELEASED INTO THE TISSUE. UPDATE REC'D 8/20/2014- PFS AND MEDICAL RECORDS RECEIVED. PART NUMBER PROVIDED. AFTER REVIEW OF THE MEDICAL RECORDS THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: 9/10/2014 UPDATE AD 30 MAY 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND STICKER SHEETS. PPF ALLEGES PSEUDOTUMOR, METAL WEAR/METALLOSIS AND ELEVATED METAL IONS. THE EVENT DESCRIPTION HAS BEEN UPDATED TO INDICATE THE ALLEGATIONS AS REVIEWED. UPDATED PRODUCT DETAILS. DOI: (B)(6) 2010, DOR: (B)(6) 2014; (RIGHT HIP).

  Patient problems: Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Pain; Test Result

  MAUDE report 7702674 ↗
• InjuryDec 12, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  THE PATIENT WAS REVISED TO ADDRESS STEM LOOSENING AT THE BONE/IMPLANT INTERFACE. DOI: UNKNOWN; DOR: (B)(6) 2017; RIGHT HIP; AWARENESS DATE: (B)(6) 2017.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7107596 ↗