Biolox 18-3605Recalls & reported problems
Howmedica Osteonics Corp. · Ceramic C-Taper Femoral Head · Class 2 · Implant
All models of Biolox (25)
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 07613154187324), received between Jan 23, 2019 and Oct 28, 2019 — classified as 2 injuries.
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 16, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Unstable1
Patient problems
- Injury2
- Joint Dislocation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 28, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
DR. REVISED A LEFT TOTAL HIP FOR THE 2ND TIME, DUE TO DISLOCATION. ORIGINAL SURGERY WAS APPROXIMATELY 15+ YEARS AGO. STEM IS A DEFINITION CEMENTED. SURGEON COMMENTED THE ABDUCTORS WERE COMPROMISED. THE FIRST WAS (B)(6) 2019. THIS REVISION WAS OF THE V-40/C-TAPER ADAPTER AND HEAD TO A NEW CUP WITH MDM. THE CUP THAT WAS IN WAS COMPETITOR. (B)(6) 2019: ACETABULAR DEVICES WERE COMPETITOR PRODUCT.
Patient problems: Injury; Joint Dislocation
MAUDE report 9246432 ↗InjuryJan 23, 2019Unstable; Unstable
IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S LEFT HIP WAS REVISED. A NOTE ON THE REVISION IMPLANT SHEET INDICATES "REVISED FOR INSTABILITY". X3 10° POLY INSERT AND 36 +5 C-TAPER BIOLOX CERAMIC HEAD WITH ADAPTER SLEEVE WERE REVISED TO A 28+8 LFIT V40 HEAD AND ADM/MDM LINER CONSTRUCT.
Patient problems: Injury
MAUDE report 8272542 ↗
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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