ASPHERE 1365-04-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295032953), received between Mar 26, 2019 and Mar 13, 2023 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (8 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. How this data works · Data updated Oct 13, 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.

• InjuryMar 13, 2023Naturally Worn; Naturally Worn

  AFTER A REVIEW OF MEDICAL RECORDS, IT WAS NOTED THAT THERE WAS SIGNIFICANT OSTEOLYSIS OF THE PROXIMAL FEMUR. HIP CAPSULECTOMY WAS DONE AND DURING THIS PROCESS, A LARGE SIGNIFICANT AMOUNT OF WHITE HEMATURIA WAS EXPRESSED FROM THE JOINT. THERE WAS EXTREMELY HIGH PRESSURE. SIGNIFICANT TRUNNIONOSIS OF THE FEMORAL TRUNNION WITH THE FEMORAL HEAD, SIGNIFICANT METALLOSIS WITH TRUNNIONOSIS. AFFECTED SIDE: LEFT HIP.

  Patient problems: Adhesion(s); Foreign Body Reaction; Hematuria; Inflammation; Loss of Range of Motion; Metal Related Pathology; Osteolysis; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 16528940 ↗
• InjuryJan 24, 2022Degraded; Naturally Worn; Degraded; Naturally Worn

  PINNACLE LITIGATION RECORDS RECEIVED. PATIENT WAS REVISED WAS DUE TO DEFECTIVE AND HEAVY METAL POISONING. LITIGATION ALLEGES PAIN, INJURIES, DISABILITY, PHYSICAL IMPAIRMENT, DISTRESS, EMOTIONAL TRAUMA, TISSUE AND BONE DESTRUCTION, WEAKNESS, INCREASED TENDERNESS OF FLEXION, INCREASED TENDERNESS OF FLEXION, METAL WEAR, PSEUDOTUMOR EXTENDING TO ILIOPSOAS TENDON SHEATH WHICH REQUIRED AND PEELING OF THE SHEATH TO REMOVE THE PSEUDOTUMOR AND BLACK CORROSION ON THE TAPER. DOI: (B)(6) 2020. DOR: (B)(6) 2021, UNK HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology; Swelling/ Edema; Synovitis

  MAUDE report 13333446 ↗
• InjuryMar 27, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE CUP, SCREW, LINER, AND HEAD WERE REVISED. THE CUP WAS VERTICAL. SCREW INFORMATION NOT AVAILABLE. DOI: (B)(6) 2010; DOR: (B)(6) 2019, (LEFT HIP).

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

  MAUDE report 9889839 ↗
• InjuryFeb 12, 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 THE PATIENT HAS HAD SEVERE PERSISTENT AND DISABLING HIP PAIN. AND WAS REVISED FOR SEVERE OSTEOLYSIS LEFT FEMUR AND ACETABULUM - LIKELY INFECTION. X-RAYS HAVE DEMONSTRATED VERY EXTENSIVE OSTEOLYSIS AROUND BOTH COMPONENTS. HE HAS SLIGHTLY ELEVATED INFLAMMATORY MARKERS BUT CONSISTENT WITH CHRONIC DISEASE. BLOOD METAL ION LEVELS INDICATED SIGNIFICANTLY INCREASED COBALT LEVEL. HIP ASPIRATION ON TWO OCCASIONS HAS DEMONSTRATED NO FINDINGS OF INFECTION. OPERATIVE NOTES REPORTED THAT APPROXIMATELY 200 CC OF NECROTIC POORLY ORGANIZED TISSUE WAS NOTED WITHIN THE JOINT. WE NOTED SOME BLACK CORROSIVE MATERIAL AROUND THE TRUNNION OF THE IMPLANT BUT NOT WITHIN THE SOFT TISSUE. THE EXTENT OF OSTEOLYSIS PERMITTED PLACEMENT OF A FINGER BETWEEN THE RESIDUAL POSTERIOR AND SUPERIOR LATERAL BONE. DOII: (B)(6) 2010; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Inflammation; Necrosis; No Code Available; Osteolysis; Pain; Test Result

  MAUDE report 9700243 ↗
• InjuryJul 30, 2019Corroded; Naturally Worn; Corroded; Naturally Worn

  AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS PAIN. INTRAOPERATIVE FINDINGS REPORTED OF LARGE AMOUNT OF FLUID THAT CAME FROM THE ILIOPSOAS BURSA. THERE WAS EXTENSIVE CORROSION BETWEEN THE COBALT CHROME AML STEM AND THE COBALT CHROME BALL. THERE WAS ALSO EXTENSIVE CORROSION ON THE BACK OF THE METAL INSERT BETWEEN THE INSERT AND THE DEPUY SHELL. THERE WAS ALSO A METALLIC DEBRIS AROUND THE TRUNNION. THE SCREWS REMOVED FROM THE ACETABULUM AS THEIR UTILITY HAD LONG SINCE PASSED AND SHOULDN'T COMPLICATE FOR THE POLYETHYLENE BEARING. THE 2 UNKNOWN HIP IMPLANT AND UNKNOWN STEM WERE UPDATE. CUP AND 1 SCREW WERE ADDED DUE TO REVISION FINDINGS.

  Patient problems: Edema; Foreign Body Reaction; Limited Mobility Of The Implanted Joint; Necrosis; No Code Available; Osteolysis; Pain

  MAUDE report 8840666 ↗
• InjuryMay 3, 2019Naturally Worn; Naturally Worn

  LITIGATION ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2010 - DOR: (B)(6) 2014 (RIGHT HIP).

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

  MAUDE report 8578561 ↗
• InjuryMay 3, 2019Material Disintegration; Biocompatibility; Naturally Worn; Material Disintegration; Biocompatibility; Naturally Worn

  PPF ALLEGES METAL WEAR/METALLOSIS AND ELEVATED METAL IONS. DOI: (B)(6) 2010; DOR: (B)(6) 2014; (LEFT HIP).

  Patient problems: Test Result; Tissue Damage

  MAUDE report 8577475 ↗
• InjuryApr 29, 2019Naturally Worn; Naturally Worn

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES METALLOSIS, METAL WEAR AND ELEVATED METAL IONS. DOI: (B)(6) 2010; DOR: (B)(6) 2015; RIGHT HIP.

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

  MAUDE report 8562548 ↗
• InjuryApr 24, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGED CLOSED DISLOCATION, INFECTION AND LOOSENING OF CUP AND STEM AFTER FIRST REVISION. DOI: (B)(6) 2011 - DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 8543725 ↗
• MalfunctionMar 26, 2019Naturally Worn; Naturally Worn

  PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. MEDICAL RECORDS HAS NO REVISION NOTES PROVIDED. DOI: (B)(6) 2010 - DOR: NOT REPORTED (LEFT HIP).

  Patient problems: Test Result; Tissue Damage

  MAUDE report 8452214 ↗