Biolox 6570-0-328Recalls & reported problems
Howmedica Osteonics Corp. · Ceramic V40 Femoral Head · Class 2 · Implant
All models of Biolox (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540608550), received between Oct 15, 2019 and Sep 16, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Fracture1
- Insufficient Device Problem Information1
Patient problems
- Fall1
- Injury1
- Joint Dislocation1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
PATIENT RECEIVED PRIMARY THA. THE THA WAS REVISED IN THE FUTURE (REASON UNKNOWN) RESTORATION MODULAR AND MDM. PATIENT THEN HAD A DISASSOCIATION OF MDM AFTER THE FIRST REVISION. PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM ON (B)(6) 2024 FOR MDM REVISION. UPDATE 09/SEPTEMBER/2024: SPOKE TO REP. REP CONFIRMED SURGICAL PROTOCOL WAS FOLLOWED EXACTLY. NOTHING UNUSUAL FOR ASSEMBLY OR IMPLANTATION. THE HEAD IS CHECKED EACH TIME TO ENSURE THAT IT IS PROPERLY SEATED.
Patient problems: Joint Dislocation
MAUDE report 20233613 ↗InjuryMar 9, 2023Fracture; Fracture
"FRACTURE OF BIOLOX CERAMIC HEAD" WAS REPORTED. UPDATE: WAS THE PATIENT DOING ANY ACTIVITY/ACTIVITIES THAT MAY HAVE LED TO THE FRACTURE?: THE PATIENT FELL
Patient problems: Fall
MAUDE report 16511413 ↗InjuryOct 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT PRESENTED TO OR TODAY WITH POSSIBLE LEFT HIP INFECTION. DR WHO ORIGINALLY DID HER HIP REPLACEMENT ON (B)(6) 2016 , WANTED TO PROCEED WITH AN IRRIGATION AND DEBRIDEMENT INCLUDING A HEAD EXCHANGE DURING PROCEDURE.
Patient problems: Injury; Unspecified Infection
MAUDE report 9191851 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 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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