NA 04.402.009SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982128065), received between Jan 24, 2019 and Apr 15, 2020 — classified as 4 injuries.

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

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A REMOVAL OF THE LEFT ELBOW DUE TO PAINFUL RETAINED HARDWARE INVOLVING THE RADIAL HEAD REPLACEMENT FROM SYNTHES. ON (B)(6) 2014, THE PATIENT HAD A LEFT RADIAL HEAD FRACTURE AND UNDERWENT A REPLACEMENT OF THE LEFT RADIAL HEAD UTILIZING THE SYNTHES SIZE 24 STANDARD HEAD AND A SIZE 9 MM STRAIGHT STEM. CONCOMITANT DEVICES REPORTED: 24MM COCR RADIAL HEAD STANDARD HEIGHT/13.0MM-STERILE (PART NUMBER 09.402.024S, LOT 7504369, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 9MM TI STRAIGHT RADIAL STEM 30MM-STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 9962335 ↗
• InjuryMay 28, 2019Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REMOVAL OF COBALT CHROMIUM RADIAL HEAD STANDARD HEIGHT-STERILE & TITANIUM STRAIGHT RADIAL STEM-STERILE, DUE TO LOOSENING OF RADIAL PROSTHESIS STEM. THE HARDWARE WAS REMOVED UNEVENTFULLY, AND THE PATIENT UNDERWENT A RADIAL HEAD RESECTION AND ADVANCEMENT OF THE LATERAL LIGAMENT. PATIENT WAS ORIGINALLY TREATED WITH RADIAL HEAD PROSTHESIS FOR RADIAL HEAD FRACTURE ON (B)(6) 2013. PROCEDURE OUTCOME WAS UNKNOWN. THE PATIENT EXPERIENCED PAIN AND ELBOW INSTABILITY. THIS REPORT IS FOR ONE (1) RADIAL STEM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 8645454 ↗
• 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 8274949 ↗
• 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 8274881 ↗

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