UNI-ELBOW 410-0008Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00886385026015), received between Apr 21, 2020 and Apr 21, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2020Loss of Osseointegration; Device Dislodged or Dislocated; Loss of Osseointegration; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT ALLEGEDLY FOLLOWING HER RE-REVISION SURGERY, ON (B)(6) 2019 SHE PRESENTED WITH COMPLAINTS OF SEVERE PAIN AND SUBLUXATION OF HER LEFT ELBOW AFTER LIFTING A LAUNDRY BAG. ALLEGEDLY X-RAYS CONFIRMED LOOSENING OF THE RE-REVISED RADIAL HEAD IMPLANT AND DURING THIS VISIT THE SURGEON TOLD HER THAT THE IMPLANT HAD BEEN RECALLED AND REMOVED FROM THE MARKET. HE RECOMMENDED SHE UNDERGO REMOVAL OF THE RADIAL HEAD PROSTHESIS WITHOUT REVISING THE PROSTHESIS WITH ANOTHER COMPONENT. IT IS FURTHER ALLEGED THAT SHE UNDERWENT REMOVAL ON OR ABOUT (B)(6) 2019 AND DURING THE SURGERY THE RADIAL HEAD COMPONENT WAS FOUND TO HAVE DISLOCATED/DISASSOCIATED FROM THE RADIAL STEM.

  Patient problems: Failure of Implant; Injury; Loss of Range of Motion; Pain

  MAUDE report 9984026 ↗
• InjuryApr 21, 2020Loss of Osseointegration; Device Dislodged or Dislocated; Loss of Osseointegration; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT ALLEGEDLY FOLLOWING HER REVISION SURGERY, IN (B)(6) 2017 SHE PRESENTED WITH SEVERE PAIN IN HER ELBOW AND AFTER PERFORMING A SERIES OF IMAGE STUDIES HER SURGEON CONFIRMED LOOSENING OF THE REVISED RADIAL HEAD IMPLANT AND FURTHER DIAGNOSED HER WITH LEFT ELBOW COLLATERAL LIGAMENT INSUFFICIENT. IT IS FURTHER ALLEGED THAT DURING THE REVISION SURGERY ON (B)(6) 2017 THE SURGEON FOUND THE RADIAL HEAD TO HAVE DISLOCATED/DISASSOCIATED FROM THE RADIAL STEM. ALLEGEDLY THE RADIAL HEAD COMPONENT WAS REVISED WITH ANOTHER STRYKER RADIAL HEAD IMPLANT.

  Patient problems: Failure of Implant; Injury; Loss of Range of Motion; Pain

  MAUDE report 9983893 ↗
• InjuryApr 21, 2020Loss of Osseointegration; Device Dislodged or Dislocated; Loss of Osseointegration; 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 9983789 ↗