BIOLOX DELTA Femoral Head (REF 5010.42.281)Recalls & reported problems
Limacorporate SPA · Biolox Delta Head 28mm #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 08033390007177), received between Mar 25, 2025 and Mar 25, 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
- 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.
InjuryMar 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
HIP REVISION SURGERY PERFORMED ON (B)(6) 2024, DUE TO INFECTION. DAIR PROCEDURE WAS PLANNED, THE WOUND WAS WASHED OUT. THE FOLLOWING DEVICES WERE EXPLANTED: FEMORAL MODULAR HEAD - S Ø28MM (PRODUCT CODE 5010.42.281, LOT #1980083 - STER. (B)(4)), MOBILE LINER ØINT 28 MM Ø42 MM (PRODUCT CODE 5566.54.420, LOT #2005166 - STER. (B)(4)) - PRODUCT NOT SOLD IN THE US. THEY GOT REPLACED WITH THE SAME SIZE IMPLANTS. IT WAS REPORTED THAT THE LINER #L FOR MOBILE LINER Ø42 (PRODUCT CODE 5885.09.042, LOT #2114275 - STER. (B)(4)) WAS UNABLE TO BE REMOVED, SO IT WAS DECIDED TO LEAVE IN SITU. ACCORDING TO THE RECEIVED INFORMATION, THE WOUND DID NOT APPEAR VERY INFECTED. SPECIMENS WERE TAKEN, BUT RESULTS AREN'T ACCESSIBLE. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2023. IT WAS A REVISION SURGERY OF THE PRIMARY IMPLANT, WHICH WAS FROM A COMPETITOR. THE DATE OF THE PRIMARY IMPLANT IS UNKNOWN. PATIENT'S CLINICAL DATA AREN'T AVAILABLE. EVENT HAPPENED IN NEW ZEALAND.
Patient problems: Medical device site infection
MAUDE report 21688253 ↗
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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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