ASPHERE 1365-07-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295033011), received between Aug 10, 2017 and Aug 12, 2024 — classified as 13 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORD RECEIVED. PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010 AND HAD A HIP REVISION ON (B)(6) 2023. OPERATIVE NOTES INDICATED BLACK-COLORED SYNOVIAL FLUID AND THE CAPSULE WAS COATED IN A RIND OF ADVERSE LOCAL TISSUE REACTION/METALLOSIS. DOI: (B)(6) 2010. DOR: (B)(6) 2023. LEFT HIP.

  Patient problems: Foreign Body Reaction; Swelling/ Edema

  MAUDE report 19959943 ↗
• InjuryApr 3, 2023Corroded; Naturally Worn; Corroded; Naturally Worn

  UPDATED EVENT DESCRIPTION: DURING THE REVISION PROCEDURE, SIGNIFICANT CLOUDY JOINT EFFUSION CONSISTENT WITH REACTION TO A METAL-ON-METAL BEARING, SMALL AMOUNT OF CORROSION AT THE HEAD NECK JUNCTION ON THE STEM, WELL FIXED COMPONENTS, LARGE ANTERIOR OSTEOPHYTE. THE HIP WAS ASPIRATED OF CLOUDY JOINT FLUID CONSISTENT WITH A METAL-ON-METAL BEARING. THERE WAS SOME SYNOVITIS, CONSISTENT WITH A METAL-ON-METAL BEARING. DOI: (B)(6) 2009, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Distress; Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Pain; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 16663506 ↗
• InjuryOct 6, 2022Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION COMPLAINT RECEIVED AD (B)(6) 2022. PATIENT WAS REVISED WAS DUE TO PAIN, TOXIC LEVELS OF COBALT AND CHROMIUM, MRI SHOWED CONSISTENT METALLOSIS. DOI: 2011. DOR: (B)(6) 2022. RIGHT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Metal Related Pathology; Pain; Physical Asymmetry; Swelling/ Edema

  MAUDE report 15551057 ↗
• InjuryJun 30, 2022Degraded; Naturally Worn; Degraded; Naturally Worn

  (B)(6) LITIGATION RECORD RECEIVED. LITIGATION ALLEGES HEAVY METAL POISONING FROM THE TOXIC HEAVY METALS RESULTING TO MUSCLE, TISSUE AND BONE INJURY, METALLOSIS, METAL WEAR, SCAR TISSUE FORMATION, PAIN AND LIMITED ADL. ALSO SUFFERED EMOTIONAL TRAUMA AND DISTRESS. DOI: (B)(6) 2010; DOR: (B)(6) 2021; RIGHT HIP.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Anxiety; Depression; Discomfort; Distress; Extraskeletal ossification; Fibrosis; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Loss of Range of Motion; Metal Related Pathology; Muscular Rigidity; Osteolysis; Pain; Scar Tissue; Synovitis; Unspecified Tissue Injury

  MAUDE report 14874969 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT INDICATED THAT THE PATIENT HAS A METAL ON METAL HIP IMPLANT. NO ALLEGATIONS WERE REPORTED. DOI: (B)(6) 2009. DOR: NONE REPORTED, (RIGHT HIP).

  Patient problems: No Code Available; Test Result

  MAUDE report 9911161 ↗
• InjuryAug 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEET RECEIVED. PPF ALLEGES INFECTION AND ELEVATED METAL IONS AFTER FIRST REVISION. LINER IS NON-DEPUY. DOI: (B)(6) 2008 (CUP AND STEM). DOI: (B)(6) 2010 (FEMORAL HEAD). DOR: (B)(6) 2010 LEFT HIP.

  Patient problems: No Code Available; Test Result; Unspecified Infection

  MAUDE report 8889339 ↗
• InjuryJun 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS ELEVATED METAL ION LEVELS AND PAIN. REVISION NOTES REPORTED SOME METAL STAINING IN THE SOFT TISSUES. CLINIC VISITS REPORTED PAIN, DISCOMFORT, DECREASED MOBILITY, LIMPING, SLEEPING DIFFICULTY, STIFFNESS, TENDERNESS AND WEAKNESS. DOI: (B)(6) 2009 - DOR: (B)(6) 2017 (LEFT HIP).

  Patient problems: Discomfort; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Test Result; Weakness

  MAUDE report 8674822 ↗
• InjuryApr 10, 2019Naturally Worn; Naturally Worn

  PPF RECORD RECEIVED. PPF ALLEGES PSEUDOTUMOR, ABDUCTOR MUSCLE REPAIR, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS.

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

  MAUDE report 8501704 ↗
• InjuryFeb 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8310126 ↗
• InjuryMay 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE PFF RECORD RECEIVED. PFF ALLEGES ABDUCTOR MUSCLE REPAIR AND INFECTION REQUIRING IV ANTIBIOTICS. DOI: (B)(6) 2010; DOR: (B)(6) 2010; RIGHT HIP.

  Patient problems: Not Applicable; Tissue Damage; Unspecified Infection

  MAUDE report 7545447 ↗
• InjuryMay 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION RECEIVED. LITIGATION ALLEGES INJURY, PAIN, ELEVATED METAL IONS, WALKING DIFFICULTY, WEAKNESS, LACK OF MOBILITY AND EMOTIONAL DISTRESS. IT WAS ALSO STATED IN LITIGATION THAT DURING PROCEDURE THE SURGEON FOUND A LARGE AMOUNT OF PURULENT FLUID WHICH WAS INFECTED. HEAD AND LINER WERE REMOVED AND IMPLANTED WITH DEPUY POLY LINER AND CERAMIC HEAD. LABORATORY RESULTS FOR METAL IONS WERE BELOW 7(NO UNIT PROVIDED). DOI: (B)(6) 2011; DOR: (B)(6) 2016 ; LEFT HIP. (B)(4)- 2ND REVISION.

  Patient problems: Distress; Injury; Limited Mobility Of The Implanted Joint; No Code Available; Not Applicable; Pain; Unspecified Infection; Weakness

  MAUDE report 7499396 ↗
• InjuryJan 24, 2018Material Disintegration; Naturally Worn; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Material Disintegration; Naturally Worn; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED TO ADDRESS HIP AND GROIN PAIN. DOI: (B)(6) 2010; DOR: (B)(6) 2018 LEFT HIP.

  Patient problems: Deformity/ Disfigurement; Discomfort; Distress; Host-Tissue Reaction; Injury; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; No Code Available; Not Applicable; Pain

  MAUDE report 7215054 ↗
• InjuryAug 10, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND ELEVATED ION LEVELS.

  Patient problems: No Information

  MAUDE report 6784882 ↗