ANTHOLOGY 71356006Recalls & reported problems
Smith & Nephew, Inc. · ANTHOLOGY STANDARD OFFSET POROUS SIZE 6 · Class 3 · Implant
All models of ANTHOLOGY (69)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010567765), received between Jun 9, 2020 and Oct 24, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Biocompatibility” (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
- Biocompatibility1
- Delivered as Unsterile Product1
- Unstable1
Patient problems
- Infiltration into Tissue1
- Injury1
- Joint Disorder1
- No Clinical Signs, Symptoms or Conditions1
- Synovitis1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT, DURING THR SURGERY, IT WAS NOTICED THAT THE BOX OF ONE (1) ANTHOLOGY SO POROUS SIZE 6 HAD A HOLE IN IT, AND DID NOT KNOW IF IT WAS STILL STERILE. A BACK UP STEM WAS AVAILABLE IN THE ROOM, THEN THEY WERE FINE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20530014 ↗InjuryMay 19, 2022Biocompatibility; Biocompatibility
IT WAS REPORTED THAT, AFTER A LEFT BHR-THA WAS PERFORMED ON (B)(6) 2010 DUE TO DEGENERATIVE ARTHRITIS, THE PATIENT EXPERIENCED INCREASING COBALT AND CHROMIUM LEVELS. AN MRI SHOWED FLUID COLLECTION WITH SYNOVIAL THICKENING, CONSISTENT WITH ADVERSE LOCAL TISSUE REACTION. THIS ADVERSE EVENT WAS TREATED WITH A LEFT REVISION SURGERY ON (B)(6) 2021. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Infiltration into Tissue; Synovitis
MAUDE report 14438332 ↗InjuryJun 9, 2020Unstable; Unstable
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE LEFT HIP DUE TO FAIL THA, WITH GROSSLY LOOSE AND UNSTABLE FEMORAL COMPONENT.
Patient problems: Injury; Joint Disorder
MAUDE report 10133521 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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