BIOLOX delta 71325154Recalls & reported problems
Smith & Nephew, Inc. · R3 36MM ID US DELTA LINER 54MM OD · Class 3 · Implant
All models of BIOLOX delta (11)
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 00885556498699), received between Jul 29, 2020 and Jul 29, 2020 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT, WHO HAD UNDERGONE A THR IN SITU FROM 2011, RECENTLY FELL AT WORK AND WAS NON-WEIGHT BEARING SINCE. X-RAYS POST-FALL WERE INCONCLUSIVE, AND A PLAN WAS MADE TO REVISE THE HEAD, LINER, AND ALSO THE CUP IF REQUIRED. DURING REVISION SURGERY, IT WAS DETERMINED THAT THE STEM HAD A GOOD FIXATION BUT THE CUP WAS LOOSE. THE R3 3 HOLE ACETABULAR SHELL 56MM, R3 36MM ID US DELTA LINER 54MM OD, BIOLOX DELTA HEAD 36 MM 12/14 S / +0, AND 2 SCREWS WERE REVISED AND 56 MULTIHOLE CUP, 5 SCREWS, 56/36 CERAMIC LINER, 36+0 CERAMIC HEAD WERE IMPLANTED INSTEAD. THE PATIENT OUTCOME IS UNKNOWN.
Patient problems: Failure of Implant
MAUDE report 10338158 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented devices
- BIOLOX DELTA 1365-36-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented839 reports
- BIOLOX DELTA 1365-36-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented643 reports
- PINNACLE POROCOAT 1217-22-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented335 reports
- PINNACLE POROCOAT 1217-22-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented263 reports
- BIOLOX DELTA 1365-36-330Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented255 reports
- PINNACLE POROCOAT 1217-22-050Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented253 reports
- PINNACLE POROCOAT 1217-22-056Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented220 reports
- SUMMIT POROCOAT 1570-11-120Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1 death204 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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