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ASPHERE 1365-36-100Recalls & reported problems

Depuy (Ireland) · ASPHERE M-SPEC METAL FEMORAL HEAD 11/13 TAPER Diameter 36mm +12 OFFSET · Class 2 · Implant

All models of ASPHERE (19)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295033554), received between Sep 28, 2018 and Sep 28, 2018 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Code Available1
  • Unspecified Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PENDING PRODUCT LIABILITY, CUSTOMER ALLEGES INFECTION AFTER FIRST REVISION.

    Patient problems: No Code Available; Unspecified Infection

    MAUDE report 7920439 ↗

Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices

All PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices →

Sources and updates

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