BIOLOX DELTA 5010.42.283Recalls & reported problems
Limacorporate SPA · Biolox Delta - Femoral Head Dia 28 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 08033390184007), received between May 11, 2026 and May 11, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
Patient problems
- Joint Dislocation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 11, 2026Device Dislodged or Dislocated
REVISION SURGERY HAS BEEN PERFORMED ON (B)(6) 2026, DUE TO HIP DISLOCATION. DURING THE REVISION A MORE LATERALIZED FEMORAL HEAD WAS PUT IN PLACE TO ACHIEVE STABILITY: PRE-EXISTING FEMORAL HEAD BIOLOX DELTA DIA. 25MM LONG TAPER 12/14 (PN: 5010.42.283, LOT. 7012012509) HAS BEEN EXPLANTED AND REPLACED WITH COCRMO FEMORAL HEAD DIA 28MM X-LONG TAPER 12/14 (PN: 5010.09.284). PREVIOUS SURGERY HAS BEEN PERFORMED ON (B)(6) 2026, DUE TO FRACTURE AND FOLLOWING COMPONENTS WERE IMPLANTED: - UNCEMENTED STEM DIA. 22MM L. 200MM (PN: 3818.15.020, LOT. 1602794, STER. 2100154). - NECK WITH SCREW (PN: 7515.15.120, LOT. 2227675, STER. 2300029). - FEMORAL HEAD BIOLOX DELTA DIA. 25MM (PN: 5010.42.283, LOT. 7012012509). PATIENT IS MALE, DATE OF BIRTH ON (B)(6) 1948. EVENT OCCURRED IN THE UNITED STATES.
Patient problems: Joint Dislocation
MAUDE report 25134382 ↗
Other Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous devices
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- 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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