ANTHOLOGY 71356012Recalls & reported problems
Smith & Nephew, Inc. · ANTHOLOGY STANDARD OFFSET POROUS SIZE 12 · Class 3 · Implant
All models of ANTHOLOGY (69)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010567826), received between Jul 18, 2024 and Oct 16, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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
- Delivered as Unsterile Product1
- Loss of Osseointegration1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- Inadequate Osseointegration1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 16, 2025Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT, ONE (1) ANTHOLOGY SO POROUS SZ 12 BROKE THROUGH PACKAGING. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23310758 ↗InjuryJul 18, 2024Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT, AFTER A LEFT THR SURGERY PERFORMED ON (B)(6) 2008 DUE TO A POST TRAUMATIC ARTHRITIS AND SEVERE PAIN, THE PATIENT STARTED EXPERIENCING PAIN IN HIS LEFT HIP. ON (B)(6) 2021 A BLOOD TEST WAS PERFORMED AND LEVELS OF CHROMIUM AND COBALT WERE AT 1.0 NG/ML AND 3.3 NG/ML, RESPECTIVELY. A BONE SCAN WAS PERFORMED ON (B)(6) 2021 THAT SHOWS FOCALLY INCREASED DELAYED ACTIVITY AT THE DISTAL MARGIN OF THE LEFT FEMORAL STEM POSSIBLY FROM EARLY LOOSING. THE PATIENT'S CONDITION IS ONGOING, REPORTING A CONSTANT 2 ON THE PAIN SCALE, AND UP TO 7. PATIENT IS SEEKING FOR HELP.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 19773202 ↗
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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