BIOLOX DELTA 5010.42.362Recalls & reported problems
Limacorporate SPA · Biolox Delta - Femoral Head Dia 36 mm #M · 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 08033390184090), received between May 23, 2025 and May 23, 2025 — 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 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO IMPLANT DISLOCATION. THE CAUSE OF THE EVENT IS UNKNOWN. THE FOLLOWING COMPONENT WERE INVOLVED IN THIS EVENT: MINIMA S LATERALIZED STEM #4 (PART CODE 4504.21.040, LOT NUMBER 2424360, STERILIZATION (B)(4)). FEM. MODULAR HEAD - M Ø36MM (PART CODE 5010.42.362, LOT NUMBER 7011910228). DELTA TT PRO D.52MM MEDIUM+ (PART CODE 5553.14.523, LOT NUMBER 2404552, STERILIZATION (B)(4)). DELTA NEUTR. LINER D.36MM #M+ (PART CODE 5885.54.259, LOT NUMBER 24AT0AH, STERILIZATION (B)(4)). BONE SCREW Ø6,5 H.25MM (PART CODE 8420.15.020, LOT NUMBER 2432222, STERILIZATION (B)(4)). DURING THE REVISION SURGERY, THE FEM. MODULAR HEAD REMOVED WAS REPLACED BY A NEW FEM. MODULAR HEAD (PART CODE 5010.42.282, LOT 7011590704). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2025. PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1947. THE EVENT HAPPENED IN THE UNITED STATES.
Patient problems: Joint Dislocation
MAUDE report 22077918 ↗
Other Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous devices
- Accolade 6021-0537Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous46 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page