ASPHERE 1365-55-100Recalls & reported problems
Depuy (Ireland) · ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 36mm +15.5 OFFSET · Class 3 · Implant
All models of ASPHERE (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295034001), received between Jan 12, 2023 and Sep 21, 2023 — classified as 2 injuries.
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. 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
- Device Dislodged or Dislocated1
Patient problems
- Joint Dislocation1
- Joint Laxity1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO INSTABILITY, AND THE STEM, HEAD, AND LINER WERE REMOVED. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2012; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT HIP.
Patient problems: Joint Laxity
MAUDE report 17788069 ↗InjuryJan 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE ORIGINAL IMPLANT DATE UNKNOWN. PRIMARY DONE AT UNKNOWN DATE, PATIENTS HIP WAS DISLOCATED AND COULD NOT BE PUT BACK IN. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE : RIGHT HIP.
Patient problems: Joint Dislocation
MAUDE report 16148239 ↗
Other Prosthesis, hip, semi-constrained (metal uncemented acetabular component) devices
- BIOLOX DELTA 1365-32-730Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)93 reports
- RingLoc® Hip System 103531Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)1 recall0 reports
- BIOLOX DELTA 1365-28-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)43 reports
- ASPHERE 1365-52-100Depuy (Ireland) · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)39 reports
- ASPHERE 1365-06-100Depuy (Ireland) · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)29 reports
- ASPHERE 1365-05-100Depuy (Ireland) · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)29 reports
- Taperloc Complete Micro Primary Femoral 51-107130Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)23 reports
- Taperloc Complete Micro Primary Femoral 51-107120Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained (metal uncemented acetabular component)19 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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