NA 09.402.224SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982132666), 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 (B)(6) 2015, THE PATIENT UNDERWENT REMOVAL SURGERY OF THE RADIAL HEAD PROSTHESIS DUE TO LOOSENING. ORIGINALLY, THE RADIAL HEAD IMPLANT SYSTEM WAS IMPLANTED ON (B)(6) 2015. FOLLOWING THE IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE INCREASING PAIN, DECREASED FUNCTION AND WEAKNESS OF HIS ELBOW AND LOSS OF RANGE OF MOTION. THE IMPLANTS WERE REMOVED WITHOUT REPLACEMENT OF THE RADIAL HEAD. DURING THE REMOVAL, IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. AFTER THE IMPLANT REMOVAL, THE PATIENT CONTINUED TO EXPERIENCE WORSENING PAIN AND INSTABILITY IN HIS RIGHT ARM. ON (B)(6) 2017, UPON CLINIC VISIT, THE PATIENT REPORTED THAT THE RIGHT ELBOW STILL HAD OCCASIONAL SEVERE SHARP PAIN WITH MECHANICAL SYMPTOMS FROM LOOSE RADIAL HEAD ARTHROPLASTY.

  Patient problems: No Code Available; Pain

  MAUDE report 8274867 ↗

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