BASIS 71312262Recalls & reported problems
Smith & Nephew, Inc. · BASIS 12/14 TAPER PRIMARY COLLARED STEM SIZE 2 · 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 03596010412911), received between Nov 2, 2022 and Nov 2, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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.
Most reported problems
Device problems
- Fracture1
Patient problems
- Ambulation or Postural Difficulties1
- 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.
InjuryNov 2, 2022Fracture; Fracture
IT WAS REPORTED THAT AFTER A THR SURGERY PERFORMED IN 2019, THE PATIENT REPORTED PAIN AND HASN'T BEEN ABLE TO WALK. AFTER TAKING X-RAYS IT WAS IDENTIFIED THAT THE BASIS 12/14 TPR PRI CLLD SZ 2 WAS FRACTURED AROUND 2 CM FROM THE TIP OF THE IMPLANT DISTALLY. A REVISION SURGERY IS RECOMMENDED BY THE PHYSICIAN BUT THE PATIENT REFUSES TO DO IT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Ambulation or Postural Difficulties; Failure of Implant
MAUDE report 15715006 ↗
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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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