OXINIUM 71342364Recalls & reported problems
Smith & Nephew, Inc. · OXINIUM FEMORAL HEAD 14/16 TAPER 36MM +4 NECK · Class 2 · Implant
All models of OXINIUM (36)
Data updated Oct 16, 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 03596010502278), received between Jun 10, 2022 and Jun 10, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (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
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2022Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT, DURING A THA SURGERY PERFORMED ON (B)(6) 2022, A OXINIUM FEMORAL HEAD 14/16 TAPER 36MM +4 NECK WAS IMPLANTED BY MISTAKE, AS IT WAS NOT NOTICED THAT IT WAS THE INCORRECT SIZE. PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022 TO REPLACE THE OXINIUM FEMORAL HEAD 14/16 TAPER 36MM +4 NECK WITH THE APPROPRIATE 12/14 TAPER OXINIUM HEAD. PATIENT DID NOT REPORT ANY SYMPTOMS PRIOR TO THE REVISION. PATIENT IS RECOVERING FROM SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14655113 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
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- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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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