NA 09.402.422SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982132710), received between Jan 24, 2019 and Jan 24, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Device Slipped” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K112030); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 24, 2019Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON OR ABOUT (B)(6) 2015, PATIENT UNDERWENT SURGERY FOR HIS RIGHT ELBOW RADIAL HEAD REPLACEMENT. DURING THE SURGERY, PATIENT WAS IMPLANTED WITH RADIAL HEAD IMPLANT. FOLLOWING THE REPLACEMENT SURGERY, PATIENT BEGAN TO EXPERIENCE INCREASING PAIN AND DECREASED FUNCTION OF HIS ELBOW AND WAS PRESENTED TO ORTHOPEDIC SURGEON, WHO CONFIRMED THE LOOSENING OF THE RADIAL HEAD PROSTHESIS. ON THE SURGEON'S RECOMMENDATION, ON OR ABOUT (B)(6) 2015, PATIENT UNDERWENT REMOVAL OF THE RADIAL HEAD PROSTHESIS WITHOUT REPLACEMENT OF THE RADIAL HEAD. THE SURGEON RECOMMENDED NOT TO REPLACE THE RADIAL HEAD COMPONENT UNLESS PATIENT SUBSEQUENTLY EXPERIENCE INSTABILITY AND PAIN OF THE ELBOW. WITHIN A FEW MONTHS OF THE IMPLANT BEING REMOVED, PATIENT DEVELOPED WORSENING PAIN AND INSTABILITY OF HIS RIGHT ARM WHICH NECESSITATED REPLACEMENT OF THE RADIAL HEAD PROSTHESIS. ON OR ABOUT (B)(6) 2016, PATIENT UNDERWENT SURGERY TO REPLACE THE RIGHT ELBOW RADIAL HEAD. PATIENT WAS REVISED WITH RADIAL HEAD IMPLANT SYSTEM. AFTER THE REVISION SURGERY, PATIENT BEGAN TO DEVELOP PAIN IN HIS ELBOW AND PRESENTED BACK TO HIS ORTHOPEDIC DOCTOR, WHO CONFIRMED LOOSENING OF THE REVISED RADIAL HEAD IMPLANT AND RECOMM

  Patient problems: Loss of Range of Motion; No Code Available; Pain; Weakness

  MAUDE report 8274885 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112030. One submission often covers many models, so check the product and lot details in each record.

• Z-1124-2017 · Dec 29, 2016 · Terminated
  Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.
• Z-1238-2013 · Feb 22, 2013 · Terminated
  Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and