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ASPHERE 1365-34-100Recalls & reported problems

Depuy (Ireland) · ASPHERE M-SPEC METAL FEMORAL HEAD 11/13 TAPER Diameter 36mm +9 OFFSET · Class 3 · Implant

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 10603295033530), received between Nov 15, 2018 and Nov 15, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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

Device problems

  • Device Dislodged or Dislocated1

Patient problems

  • Failure of Implant1
  • Joint Dislocation1

Recent adverse event reports

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

  • InjuryNov 15, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

    PPF AND IMPLANT RECORD RECEIVED. PPF ALLEGES DISLOCATION.

    Patient problems: Failure of Implant; Joint Dislocation

    MAUDE report 8075112 ↗

Other Prosthesis, hip, semi-constrained (metal uncemented acetabular component) devices

All Prosthesis, hip, semi-constrained (metal uncemented acetabular component) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.