UNI-ELBOW 410-0001Recalls & reported problems
Stryker GmbH · Radio Capitellum Small, Left · Class 2 · Implant
Data updated Oct 18, 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 00886385025940), received between Apr 21, 2020 and Apr 21, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Failure of Implant1
- Injury1
- Loss of Range of Motion1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT ALLEGEDLY FOLLOWING HER REPLACEMENT SURGERY THE PATIENT BEGAN TO EXPERIENCE INCREASING PAIN AND DECREASED FUNCTION IN HER ELBOW AND HER SURGEON CONFIRMED LOOSENING OF THE RADIAL HEAD PROSTHESIS. IT IS FURTHER ALLEGED THAT DURING THE REVISION SURGERY ON (B)(6) 2015 THE SURGEON FOUND THE RADIAL HEAD COMPONENT TO HAVE DISLOCATED/DISASSOCIATED FROM THE RADIAL STEM. ALLEGEDLY THE RADIAL HEAD COMPONENT WAS REVISED WITH ANOTHER STRYKER RADIAL HEAD COMPONENT.
Patient problems: Failure of Implant; Injury; Loss of Range of Motion; Pain
MAUDE report 9981152 ↗
Other PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED devices
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- DURALOC 1241-46-526Depuy Orthopaedics, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED17 reports
- Latitude™ - Elbow DKY067Tornier, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED8 reports
- RHS - RADIAL PROSTHESIS DTJ302Tornier · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED6 reports
- Latitude™ EV 0030221Tornier, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED5 reports
- CRF II - RADIAL PROSTHESIS DTJ022Tornier · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED5 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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