ASPHERE 1365-43-600Recalls & reported problems
Depuy (Ireland) · ASPHERE M-SPEC METAL FEMORAL HEAD 11/13 TAPER Diameter 40mm +3 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 10603295033783), received between Oct 23, 2018 and Oct 14, 2019 — classified as 2 injuries.
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 Problem2
Patient problems
- Test Result2
- Hypersensitivity/Allergic reaction1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES PSEUDOTUMOR AND ELEVATED METAL IONS. DOI: (B)(6) 2011; DOR: (B)(6) 2014; (RIGHT HIP).
Patient problems: Hypersensitivity/Allergic reaction; No Code Available; Test Result
MAUDE report 9187208 ↗InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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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