BIOLOX DELTA 5010.42.323Recalls & reported problems
Limacorporate SPA · Biolox Delta - Femoral Head Dia 32 mm #L · 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 08033390179904), received between Nov 20, 2025 and Nov 20, 2025 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Medical device site infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HIP REVISION SURGERY DUE TO INFECTION PERFORMED ON (B)(6) 2025. COMPLAINT SOURCE REPORTED APPEARANCE OF HYPEREMIC TUMESCENCE WITH FISTULATION ON THE SCAR UPON ROUTINE CHECKUP, COMPATIBLE WITH ACUTE SEPTIC PHLEBITIS. EXPLANTATION, MULTIPLE SWABS AND APPLICATION OF ANTIBIOTIC SPACER. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2025 (DUE TO LEFT FEMORAL NECK FRACTURE). THE FOLLOWING DEVICES WERE EXPLANTED: DELTA PROTR.LINER ØINT 32MM #M, PRODUCT CODE 5886.54.158, LOT N. 25AT118, STER. N. 2500100 FEM. MODULAR HEAD - L Ø32MM, PRODUCT CODE 5010.42.323, LOT N. 7011917337 PATIENT IS FEMALE, 48 YEARS OLD. THIS EVENT OCCURRED IN ITALY. NOTE: ONLY THE HEAD IS CLEARED IN THE USA.
Patient problems: Medical device site infection
MAUDE report 23605997 ↗
Other Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous devices
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- PROFEMUR® PHAC1252Microport Orthopedics Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous37 reports
- 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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