AML 1554-02-106Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295058335), received between Aug 15, 2018 and Jul 12, 2023 — classified as 7 injuries.

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

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION ON (B)(6) 2023, DUE TO A FEMORAL STEM FRACTURE. A 6IN AML LRG STATURE 10.5 MM WAS FOUND TO BE BROKEN AND WAS REMOVED. SURGICAL DELAY IS UNKNOWN. THIS REPORT IS FOR A 6IN AML LRG STATURE 10.5 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17309272 ↗
• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. CUP WAS REMOVED AND REPLACED WITH REVISION COMPONENTS. LOT AND REFERENCE NUMBERS UNAVAILABLE. DOI: UNKNOWN; DOR: (B)(6) 2018 LEFT HIP.

  Patient problems: Adhesion(s); Foreign Body Reaction; No Code Available

  MAUDE report 9413325 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION (RIGHT SIDE). DOI: (B)(6) 2008 - DOR: (B)(6) 2008. UPDATE AD 11 APR 2019: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED DUE TO INFECTION OF RIGHT THA, DECREASE MOBILITY, PAIN, HIP ABSCESS, HIP POPPING AND CELLULITIS. OPERATIVE NOTE REPORTED A LESION WERE DEBRIDED, INFECTION IS IN THE HIP JOINT PROPER AND HAD A CRACKED PROXIMAL FEMUR. ADDED MANUFACTURING DATE, EXPIRATION DATE, PATIENT DEMOGRAPHICS, MEDICAL HISTORY AND PATIENT HARM. CORRECTED PATIENT IDENTIFIER. DOI: (B)(6) 2008; DOR: (B)(6) 2008; RIGHT HIP.

  Patient problems: Abscess; Bone Fracture(s); Cellulitis; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Seroma; Unspecified Infection

  MAUDE report 8946759 ↗
• InjuryApr 10, 2019Loss of Osseointegration; Loss of Osseointegration

  PPF AND IMPLANT RECORDS RECEIVED. PPF ALLEGES DISLOCATION, INFECTION, LOOSENING OF STEM, LOOSENING OF CUP AND UNKNOWN BONE FRACTURE AFTER FIRST REVISION.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Unspecified Infection

  MAUDE report 8501506 ↗
• InjuryMar 28, 2019Degraded; Fracture; Biocompatibility; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Degraded; Fracture; Biocompatibility; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  MEDICAL RECORDS RECEIVED. AFTER A REVIEW OF MEDICAL RECORDS, REVISION NOTES WERE REPORTED OF SEROUS FLUID. THE LINER, HEAD, AND STEM WERE REMOVED FROM THE CANAL WITH MINIMAL BONE ATTACHMENT. CLINIC VISITS REPORTED OF LARGE PSEUDOTUMOR, SWELLING, AND PAINFUL RIGHT LATERAL CONDYLE ABOVE THE HEAD OF THE FIBULA. PSUEDUTOMORS CONTAIN METAL IONS, OSTEOCYTES, WBCS, FLUID, AND OSTEOLYSIS. BONE SCAN REPORTED OF PERIPROSTHETIC FRACTURE. CORTICAL FRACTURE EMANATING FROM THE TIP OF THE PROSTHESIS. METAL DEBRIS GENERATED FROM TAPER JUNCTIONS APPEARS TO BE OF A DIFFERENT MORPHOLOGY. IT WAS ALSO REPORTED THAT THE IMPLANT WAS LIKELY ALREADY CORRODED WHEN IT WAS INSERTED. THERE WAS ALSO CONSISTENT OF INFLAMMATION AND SYSTEMIC COBALT TOXICITY FROM TOTAL HIP ARTHROPLASTIES. UPDATED EVENT DESCRIPTION: ON (B)(6) 2010 DURING THE CLINIC VISIT, A LARGE PSEUDOTUMOR BEGAN SWELLING, VERY HARD AND PAINFUL, ON THE RIGHT LATERAL CONDYLE ABOVE THE HEAD OF THE FIBULA, ABOUT THE SIZE OF A GOLF BALL. PSEUDOTUMORS CONTAIN METAL IONS, OSTEOCYTES, WBCS, AND FLUID. ON (B)(6) 2010, THE PATIENT HAD A RIGHT TOTAL HIP REPLACEMENT TO ADDRESS DEGENERATIVE ARTHRITIS. IT WAS NOTED THAT AN AML PROSTHESIS WAS IMPLANTED IN THE FE

  Patient problems: Cramp(s) /Muscle Spasm(s); Depression; Fall; Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inadequate Osseointegration; Inflammation; Limb Fracture; Metal Related Pathology; Muscle Spasm(s); No Code Available; Pain; Swelling/ Edema; Test Result; Tissue Damage; Unspecified Tissue Injury

  MAUDE report 8459453 ↗
• InjuryFeb 22, 2019Biocompatibility; Biocompatibility

  PPF ALLEGES METAL WEAR/METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2008 - DOR: (B)(6) 2011 (RIGHT HIP).

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

  MAUDE report 8362213 ↗
• InjuryAug 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPLAINT DESCRIPTION: LITIGATION ALLEGES THE PATIENT SUFFERS FROM PAIN, SWELLING, INFLAMMATION, INFECTION, AND DIFFICULTY AMBULATING. PPF ALLEGES INFECTION. UNKNOWN LINER AND HEAD WAS UPDATED AND ADDED CUP, SCREW AND STEM IN IMPACTED PRODUCT DUE TO ALLEGED INFECTION. DOI: (B)(6) 2009 - DOR: (B)(6) 2013 (LEFT HIP).

  Patient problems: Inflammation; Not Applicable; Pain; Swelling; Unspecified Infection

  MAUDE report 7784178 ↗