NA 09.402.222SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982132659), received between Dec 4, 2018 and Sep 30, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Slipped” (2 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 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.

• InjurySep 30, 2019Device Slipped; Unintended Movement; Device Slipped; Unintended Movement

  NO IMPLANTS SHOWN IN THE IMAGES RECEIVED.

  Patient problems: No Code Available; Pain

  MAUDE report 9134817 ↗
• InjuryJan 10, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A REVISION WITH WRIGHT MEDIAL RADIAL HEAD IMPLANT. REMOVAL WAS DUE TO A LOOSE IMPLANT. BONE LOSS AROUND THE STEM WAS ALSO REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR ONE (1) 22MM COCR RADIAL HEAD 2MM HT EXTENSION/14.5MM-STER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 8237200 ↗
• InjuryDec 4, 2018Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT REMOVAL OF RADIAL HEAD IMPLANT, OPEN REDUCTION INTERNAL FIXATION (ORIF) OF PERIPROSTHETIC LEFT PROXIMAL RADIUS FRACTURE NONUNION, AND BONE GRAFTING OF LEFT PROXIMAL RADIUS FRACTURE WITH ALLOGRAFT DUE TO A LOOSE LEFT RADIAL HEAD IMPLANT WITH PERIPROSTHETIC PROXIMAL RADIUS FRACTURE. THE RADIAL HEAD IMPLANT WAS IDENTIFIED AND NOTED TO BE VERY LOOSE. THE COUPLING SCREW BETWEEN THE HEAD AND THE STEM WAS REMOVED AND THE HEAD WAS EXPLANTED. THE STEM WAS THEN EASILY EXPLANTED AS WELL. A PARTIALLY THREADED SYNTHES 6.5MM CANNULATED SCREW WITH A SYNTHES WASHER WAS THEN USED AND PLACED OVER THE GUIDEWIRE. THERE WERE NO SIGNS OF INFECTIONS. THERE WAS EXCELLENT COMPRESSION OF THE FRACTURE SITE WITH APPROPRIATE CANNULATED SCREW PLACEMENT AND LENGTH. ORIGINALLY, THE PATIENT WAS IMPLANTED WITH 22MM RADIAL HEAD PROSTHESIS ON (B)(6) 2016, DURING RADIAL HEAD ARTHROPLASTY DUE TO RADIAL NECK FRACTURE MALUNION. ON (B)(6) 2017, THE PATIENT WENT TO THE CLINIC FOR A POSTOPERATIVE VISIT AND STATED THAT THE SYMPTOMS WORSENED COMPARED TO THE PREOPERATIVE SYMPTOMS. THE PATIENT HAD SHOWN A DECREASE IN ACTIVITY LEVEL. INCISION WAS WELL HEALED WITHOUT SIGN

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 8129775 ↗

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