BIOLOX FORTE 1365-74-000Recalls & reported problems
Depuy Orthopaedics, Inc. · BIOLOX FORTE CERAMIC FEMORAL HEAD +5 Diameter 28mm 12/14 TAPER · Class 2 · Implant
Data updated Oct 18, 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 10603295034322), received between Jan 6, 2023 and Jan 21, 2026 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Pain1
- Physical Asymmetry1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE SURGEON PERFORMED A HEAD/LINER EXCHANGE WITH NO ISSUES AND THE FINAL CONSTRUCT WAS SATISFACTORY. THE REASON FOR THE EXCHANGE IS UNKNOWN, BUT IT WAS NOTED THE NEW CONSTRUCT ADDED A FEW MILLIMETERS OF LEG LENGTH. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.
Patient problems: Physical Asymmetry
MAUDE report 24129922 ↗InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO HIP PAIN / POLY WEAR. HEAD, LINER, AND LOCKING RING EXCHANGED. ORIGINAL DATE OF SURGERY UNKNOWN. BELIEVED TO BE ABOUT 15 YEARS AGO. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: ON (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain
MAUDE report 16111838 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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