BIOLOX DELTA 5010.42.322Recalls & reported problems
Limacorporate SPA · Biolox Delta - Femoral Head Dia 32 mm #M · Class 2 · Implant
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 08033390184045), received between Jun 8, 2023 and May 14, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Physical Resistance/Sticking1
Patient problems
- Implant Pain1
- Medical device site infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2026Physical Resistance/Sticking
AFTER ONE YEAR FROM IMPLANTATION, PATIENT COMPLAINED OF PAIN AND FRICTION. REVISION SURGERY WAS PERFORMED TO CHANGE THE CERAMIC HEAD (FEM. MODULAR HEAD - M Ø32MM, CODE 5010.42.322, LOT: 7011835690) WITH A DIFFERENT SIZE. THE CUP AND THE STEM REMAINED IMPLANTED. THIS EVENT OCCURRED IN ITALY.
Patient problems: Implant Pain
MAUDE report 25168865 ↗InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HIP REVISION SURGERY DUE TO INFECTION AND INFLAMMATORY REACTION PERFORMED ON (B)(6) 2023. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2023. DURING THE REVISION SURGERY, THE FOLLOWING COMPONENTS WERE EXPLANTED: FEM. MODULAR HEAD - M Ø32MM 501042322 LOT 7011755791 . DELTA PROTR.LINER ØINT 32MM #M 588654158 LOT 22AT1ZQ. THIS EVENT OCCURRED IN ITALY.
Patient problems: Medical device site infection
MAUDE report 17086599 ↗
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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