ASPHERE 1365-31-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295033370), received between Apr 20, 2018 and Apr 20, 2023 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAINFUL RIGHT HIP. DOI: (B)(6) 2008, DOR: (B)(6) 2023, AFFECTED SIDE : RIGHT HIP.

  Patient problems: Pain

  MAUDE report 16776802 ↗
• InjuryAug 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED FOR PAINFUL RIGHT THA, METALLOSIS, AND MECHANICAL LOOSENING OF THE CUP. INTRA-OPERATIVE NOTES REPORTED THAT THERE WAS EXCESS FLUID IN THE JOINT. THE CUP WAS FOUND TO BE LOOSED AND THERE WAS SOFTENING OF ACETABULAR BONE IN THE MEDICAL WALL REGION. DOI: (B)(6) 2009; DOR: (B)(6) 2019; RIGHT HIP.

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

  MAUDE report 10368647 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS LEFT HIP MODULAR METAL-ON-METAL TOTAL HIP ARTHROPLASTY WITH ADVERSE LOCAL TISSUE REACTION AND POSSIBLE METAL TOXICITY. PATIENT HAS DEVELOPED LEFT HIP PAIN AND MILD ABDUCTOR IRRITATION BUT NO SEVERE WEAKNESS. LABORATORY STUDIES SHOWED THAT PATIENT HAD ELEVATED SERUM METAL ION LEVELS WITH COBALT GREATER THAN 8 AND CHROMIUM GREATER THAN 4. OPERATIVE NOTES STATED THAT UPON ENTRY INTO THE JOINT, THERE WAS EXPRESSION OF ONLY A VERY SCANT AMOUNT OF CLEAR, BENIGN-APPEARING STRAW-COLORED JOINT FLUID. THERE WERE A FEW, PATCHY AREAS OF DARK GRAY TO BLACK STAINED SYNOVIUM BUT THE MAJORITY OF THE PERIPROSTHETIC SYNOVIAL SOFT TISSUES WERE NOTED TO BE GROSSLY HEALTHY APPEARING WITHOUT GRANULATION, FRIABILITY, OR NECROSIS. THERE WAS NO GROSS EVIDENCE OF INFECTION. DOI: (B)(6) 2010. DOR: (B)(6) 2019 (LEFT HIP). PATIENT WAS BILATERAL. SEE (B)(4) FOR THE RIGHT HIP.

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

  MAUDE report 9843411 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PCF AND MEDICAL RECORDS RECEIVED. PCF HAS NO ALLEGATIONS REPORTED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED PAINFUL RIGHT TOTAL HIP ARTHROPLASTY WITH A METAL ON METAL BEARING, HYPERSENSITIVITY REACTION WITH A LARGE FLUID COLLECTION ON MRI. OPERATIVE NOTE REPORTED A LARGE BURSAL SAC FULL OF CLEAR YELLOW FLUID. THERE WAS NO EVIDENCE OF DAMAGE OF MUSCLE ATTACHMENT TO BONE. DOI: (B)(6) 2010. DOR: (B)(6) 2012, (RIGHT HIP).

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

  MAUDE report 9780005 ↗
• InjuryFeb 6, 2020Corroded; Degraded; Adverse Event Without Identified Device or Use Problem; Corroded; Degraded; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN AND FEMORAL COMPONENT LOOSENING. REVISION NOTES REPORTED GROSS LOOSENING OF FEMORAL COMPONENT AND SMALL AMOUNT OF CORROSION AT THE TAPER. THERE WAS NO NOTED METALLOSIS. DOI: (B)(6) 2010: DOR: (B)(6) 2013; RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9677838 ↗
• MalfunctionApr 4, 2019Naturally Worn; Naturally Worn

  PPF ALLEGES METAL WEAR AND METALLOSIS. DOI: (B)(6) 2009; DOR: NONE REPORTED, (LEFT HIP).

  Patient problems: Tissue Damage

  MAUDE report 8482285 ↗
• InjuryJan 14, 2019Material Disintegration; Naturally Worn; Material Disintegration; Naturally Worn

  IT WAS REPORTED THAT THE METAL LINER WAS CHANGED OUT TO POLY.

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

  MAUDE report 8245396 ↗
• InjuryDec 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES ELEVATED METAL IONS. LINER IS NON-METAL.

  Patient problems: Test Result

  MAUDE report 8195977 ↗
• InjuryJul 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION: THE PATIENT WAS REVISED TO SWAP OUT THE METAL ON METAL BEARING, AS WELL AS A FEMORAL STEM. NO PATIENT HARM OR DEVICE FAILURE REPORTED. UPDATE AD 11 JUN 2018: (B)(4) WAS REOPENED UNDER (B)(4) DUE TO CLAIM LETTER RECEIVED. CLAIM LETTER ALLEGES PAIN. THE PATIENT HARM HAS BEEN UPDATED. DOI: (B)(6) 2009: DOR: (B)(6) 2017; LEFT HIP.

  Patient problems: Discomfort; Distress; Injury; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Pain

  MAUDE report 7663557 ↗
• InjuryApr 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGES INCREASED RIGHT HIP AND GROIN PAIN WHICH DIMINISHED HER ABILITY TO ENGAGE IN HER ACTIVITIES OF DAILY LIVING. IT ALSO ALLEGES METALLOSIS, TISSUE NECROSIS, HEAVY METAL POISONING, LOSS OF BONE, BODILY INJURY, DISABILITY, PHYSICAL IMPAIRMENT, DISFIGUREMENT, MENTAL ANGUISH, EMOTIONAL DISTRESS, ANXIETY AND DEPRESSION. DOI: (B)(6) 2009 : DOR: (B)(6) 2017 (RIGHT HIP).

  Patient problems: Anxiety; Burning Sensation; Confusion/ Disorientation; Deformity/ Disfigurement; Depression; Distress; Extraskeletal ossification; Injury; Necrosis; No Code Available; Not Applicable; Pain; Tissue Damage

  MAUDE report 7446362 ↗