BIOLOX DELTA 5010.42.281Recalls & reported problems
Limacorporate SPA · Biolox Delta - Femoral Head Dia 28 mm #S · Class 2 · Implant
Data updated Oct 18, 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 08033390183970), received between May 28, 2025 and May 28, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO ASEPTIC LOOSENING OF THE ACETABULAR COMPONENT OF THE RIGHT HIP ARTHROPROSTHESIS. LIMACORPORATE FEM. MODULAR HEAD - S Ø28MM (PRODUCT CODE: 5010.42.281 - LOT. 2082434 - STER. (B)(4)) WAS EXPLANTED, TOGETHER WITH DEDIENNE LEGAL MANUFACTURER DEVICES ACET.CUP CEMENTED SZ.48MM / SYMBOL (PRODUCT CODE: 3700502203660 - LOT. 204780040A) AND PE-INSERT 28MM (PRODUCT CODE: 3700502203875 - LOT: 204482040A). PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2021. PATIENT 88 YEARS OLD. EVENT OCCURRED IN ITALY.
Patient problems: Failure of Implant
MAUDE report 22093980 ↗
Other Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous devices
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- Accolade 6020-0335Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous35 reports
- OXINIUM 71342340Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous32 reports
- EXETER 0580-1-351Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous29 reports
- INSTRUMENT 2101-0200Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous27 reports
- REFLECTION 71330001Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous20 reports
- Accolade 6720-0330Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous18 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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