ASPHERE 1365-33-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295033516), received between Dec 8, 2015 and Aug 27, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported on (b)(6) 2010, patient received a primary left total hip replacement to address avascular necrosis of the left femoral head, and degenerative joint disease of the left hip. Implants placed were DePuy 52 mm diameter Pinnacle 100 acetabular cup with an apex hole eliminator, 36 mm inner diameter by 52 mm outer diameter neutral Pinnacle metal acetabular insert, and a 36 mm +6 aSPHERE metal-on-metal femoral head, an S-ROM 18 x 13 femoral stem with 36 + 8 lateral off set neck, 18D small ZTT sleeve. There were no complications reported.(b)(6) 2023, the patient allegedly developed sudden onset of severe left hip and groin pain accompanied by a pulling sensation. Although some medical records reference a possible slip and fall, the patient does not recall any fall and reports that the symptoms began spontaneously. Due to worsening pain, the patient sought medical evaluation in (b)(6) 2023. Diagnostic imaging reportedly revealed osteolysis, a left lesser trochanter fracture, and significant osteolytic disease involving the proximal femur associated with a large-head Metal-on-Metal hip articulation. Subsequent Metal-on-Metal testing and metal ion studies reportedly identified

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Osteolysis

  MAUDE report 50473055 ↗
• InjuryApr 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING RIGHT HIP PAIN WHERE SHE HAD AN SROM SLEEVE, SROM STEM, 11/13 METAL HEAD, PINNACLE LINER, AND PINNACLE CUP IMPLANTED. A REVISION OF THE RIGHT HIP WAS PERFORMED BY REPLACING THE STEM, HEAD, AND LINER. RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8556687 ↗
• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES ELEVATED METAL IONS.

  Patient problems: Test Result

  MAUDE report 7996763 ↗
• InjuryNov 9, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 7013718 ↗
• InjuryNov 9, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS DISLOCATION. / INVESTIGATION METHOD: / INVESTIGATION SUMMARY.

  Patient problems: Joint Dislocation

  MAUDE report 7013661 ↗
• InjuryDec 8, 2015Naturally Worn; Appropriate Device Problem Term/Code Not Available

  LITIGATION PAPERS ALLEGE THE PATIENT DEVELOPED SYMPTOMS OF CLICKING, PAIN, DISCOMFORT, AND DIFFICUTLY WALKING APPROXIMATELY NINE MONTHS AFTER THE IMPLANT OF THE RIGHT HIP, AND THESE PROBLEMS PROGRESSIVELY WORSENED. TESTING FOR CHROMIUM AND COBALT RESULTED IN ELEVATED METALLOSIS LEVELS BY (B)(6) 2014.

  Patient problems: Discomfort; Foreign Body Reaction; Host-Tissue Reaction; No Code Available; Pain

  MAUDE report 5274388 ↗