AML 1554-03-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295058458), received between Nov 16, 2017 and Nov 2, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Corroded” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 2, 2023Fracture; Fracture

  PATIENT WAS REVISED DUE TO TRUNION AND THE BREAKAGE OFF STEM. DOI: (B)(6) 2013. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 18055395 ↗
• InjurySep 8, 2021Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  PINNACLE MOM LITIGATION RECORDS RECEIVED. LITIGATION ALLEGES HEAVY METAL POISONING FROM THE TOXIC HEAVY METALS RESULTING IN INJURY, SWELLING HIP, PAIN, NECROTIC TISSUE, PSEUDOTUMOR, DAMAGE MUSCLE AND BONE. OPERATIVE NOTE REPORTED A LARGE 1-2 L OF FLUID, EXTENSIVE DESTRUCTION OF THE PERIARTICULAR SOFT TISSUES, HIP ABDUCTOR DESTRUCTION, MULTIPLE FLUIDS COLLECTION AND COPIOUS AMOUNT OF CHOCOLATE BROWN FLUID, METAL WEAR. PATIENT IS ALSO EXPERIENCING EMOTIONAL TRAUMA AND DISTRESS. PLAINTIFF IS SEEKING COMPENSATORY DAMAGES. DOI: (B)(6) 2010; DOR: (B)(6) 2020; HIP UNKNOWN.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Extraskeletal ossification; Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Metal Related Pathology; Muscle/Tendon Damage; Necrosis; Nerve Damage; Pain; Physical Asymmetry; Pocket Erosion; Scar Tissue; Swelling/ Edema; Synovitis; Unspecified Tissue Injury

  MAUDE report 12443860 ↗
• InjuryApr 1, 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 INFECTION. REVISION NOTES STATED THAT A LARGE AMOUNT OF FLUID WAS SEEN WITHIN SUBCUTANEOUS SPACE. PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT OF THE LEFT WOUND AND LARGE VAC APPLICATION. PATIENT EXPERIENCED PAIN, SWELLING, TENDERNESS, ACTIVE ROM MODERATELY IMPAIRED, AND SEVERE SEPSIS. DOI: (B)(6) 2016, (HEAD,LINER,STEM). DOI: (B)(6) 2016, (CUP, SCREW, APEX). DOR: (B)(6) 2016, LEFT HIP.

  Patient problems: Discomfort; Loss of Range of Motion; No Code Available; Pain; Sepsis; Swelling; Unspecified Infection

  MAUDE report 9909169 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED PAIN, SEVERE SEPSIS, SEPTICEMIA, INFECTION. GENERALIZED WEAKNESS, HYPOXIA, APNEA, ASTHMA, AND PNEUMONIA. DOI: (B)(6) 2016. DOR: NONE REPORTED, (RIGHT HIP).

  Patient problems: Apnea; No Code Available; Pain; Pneumonia; Sepsis; Unspecified Infection; Weakness

  MAUDE report 9909108 ↗
• InjuryJul 17, 2019Loss of Osseointegration; Loss of Osseointegration

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL COMPONENT RESULTING TO PAIN. OPERATIVE FINDING REPORTED METALLOSIS WITH DARK METALLIC STAINING, MINIMAL SIGNS OF WEAR AND CLOUDY BROWN COLOR JOINT FLUID BUT NO SIGNS OF PURULENCE. FEMORAL COMPONENT WAS GROSSLY LOOSE. DOI: (B)(6) 2006. DOR: (B)(6) 2013. RIGHT HIP.

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

  MAUDE report 8799478 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES INJURIES, SEVERE METAL POISONING, EXCESSIVE COCR LEVELS IN THE BLOOD, METALLOSIS FROM METAL DEBRIS, PAIN AND EMOTIONAL DISTRESS. DOI: (B)(6) 2009; DOR: (B)(6) 2019; LEFT HIP.

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

  MAUDE report 8599940 ↗
• InjuryJan 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES PAIN, DISCOMFORT AND HIGH LEVELS OF METAL DEBRIS. PPF ALLEGES ELEVATED METAL IONS. DOI: (B)(6) 2004 - DOR: (B)(6) 2012 (RIGHT HIP).

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

  MAUDE report 8212039 ↗
• InjuryNov 15, 2018Corroded; Corroded

  MAUDE REPORT RECEIVED STATING THAT PATIENT HAD DEVELOPED LIMITED MOVEMENT ISSUES AND PAIN. THE PARTS WERE COBALT AND CHROMIUM. HE HAD KIDNEY FAILURE, HEART ATTACK, NUMEROUS TUMORS NEAR HIS HIP REPLACEMENT AND COBALT AND CHROMIUM POISONING. DOI: 2006; DOR: N/A; UNKNOWN HIP.

  Patient problems: Cardiac Arrest; Host-Tissue Reaction; Loss of Range of Motion; No Code Available; Pain; Renal Failure; Test Result

  MAUDE report 8075181 ↗
• InjuryNov 16, 2017Corroded; Appropriate Device Problem Term/Code Not Available; Corroded; Appropriate Device Problem Term/Code Not Available

  NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGAL SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT ¿ LITIGATION PAPERS ALLEGE THE PATIENT SUFFERS FROM PAIN AND ELEVATED METAL ION LEVELS. UPDATE 8/13/2012 - PFS WAS RECEIVED. THE PART/LOT INFORMATION WAS IDENTIFIED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE REC'D 12/07/2016 - THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS PAIN. COMPLAINT UPDATED 12/28/2016. UPDATE OCT 18, 2017: MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, PATIENT WAS ALSO REVISED TO ADDRESS PROSTHETIC WEAR AND METAL ON METAL REACTION. REVISION NOTES REPORTED MURKY, BLOOD-TINGED FLUID, BROWN THICKENED PARTICULATE DEBRIS TYPICAL FOR METAL ON METAL REACTION, DISCOLORATION, BLACK DISCOLORATION OF THE TRUNION AND NECK, BROWN STAINED REACTIVE TISSUE, AND THICKENING AND DISCOLORATION OF THE SYNOVIUM. ADDED STEM FOR THE ALLEGED ELEVATED METAL IONS. THIS COMPLAINT WAS UPDATED ON: OCT 26, 2017.

  Patient problems: Pain

  MAUDE report 7038958 ↗