SPECTRON 71312111Recalls & reported problems
Smith & Nephew, Inc. · SPECTRON EF PRIMARY HIGH OFFSET 12/14 FEMORAL SIZE 1 · Class 2 · Implant
Data updated Oct 13, 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 03596010195562), received between Jan 22, 2024 and Jan 22, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Inadequate Osseointegration1
- Osteolysis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 22, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT ON LITERATURE REVIEW "INFLAMMATORY TISSUE REACTIONS AROUND ASEPTICALLY LOOSE CEMENTED HIP PROSTHESES: A RETRIEVAL STUDY OF THE SPECTRON EF STEM WITH REFLECTION ALL-POLY ACETABULAR CUP" 93 MONTHS AFTER A THA SURGERY, WHERE AN SPECTRON EF STEM AND A REFLECTION NON-CROSSLINKED ALL-POLLY CUP WERE IMPLANTED, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING AND OSTEOLYSIS OF THE CUP, AS WELL AS LOOSENING OF THE STEM. THE STUDY DETERMINED THAT BOTH THE STEM AND THE CUP WERE WORN, ADDITIONALLY PE, CR, CO AND ZN PARTICLES WERE PRESENT IN THE PERIPROSTHETIC TISSUE. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 18557149 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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