NA 04.402.006SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982128034), received between Apr 17, 2018 and Dec 5, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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 16, 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.

• InjuryDec 5, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT REMOVAL OF LOOSE LEFT ELBOW RADIAL HEAD PROSTHESIS IMPLANT AND LOOSE RADIAL PLATE AND SCREWS AND CERCLAGE WIRE. PREVIOUS INCISION WAS OPENED AND WAS EXTENDED DISTALLY. THE SUPINATOR MUSCLE WAS OPENED OVER THE POSTERIOR OSSEOUS NERVE WHICH HAD SEVERE SCAR AROUND IT NEEDING AN EXTENSIVE NEUROLYSIS THAT WAS LENGTHY AND TOOK 3 TO 4 TIMES LONGER THAN USUAL. THE POSTERIOR INTEROSSEOUS NERVE WAS SCARRED AND STRETCHED DISTALLY NEAR THE PLATE; WAS SEVERELY SCARRED TO THE PLATE AND RADIUS BONE. WHILE PROTECTING THE NERVE, THE NERVE WAS COMPLETELY LIFTED OFF THE PLATE. PERIOSTEUM WAS OPENED TO EXPOSE THE HARDWARE. THERE WAS REDDISH FLUID AROUND THE IMPLANTS. 2 DIFFERENT IMPLANTS WERE REMOVED, ONE WAS RADIAL HEAD, THE OTHER WAS PLATES AND SCREWS AND CERCLAGE WIRE. THE RADIUS BONE WAS SHUCKED AND THE WRIST WAS COMPRESSED AND THE PROXIMAL RADIUS HAD NO PROXIMAL MIGRATION. FLUOROSCOPIC IMAGES OF ELBOW CONFIRM ALL HARDWARE WERE REMOVED. REMAINING BONE INTACT AND ULNOHUMERAL JOINT LOCATED. ON (B)(6) 2016, THE PATIENT FELL OVER A STEP AND HIT LEFT ARM ON CONCRETE WHILE SHE WAS EXERCISING TRYING TO DO A HURDLE DURING AGILITY DRILLS. THE PATIE

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 8133862 ↗
• InjuryJun 11, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A PATIENT WAS ORIGINALLY IMPLANTED WITH A 6MM TITANIUM STRAIGHT RADIAL STEM WITH A RADIAL HEAD ON (B)(6) 2016. THE PATIENT WAS REPORTED TO BE PROGRESSING FINE UNTIL RECENTLY WHEN THE PATIENT VISITED THE CLINIC WITH REPORTS OF PAIN IN THE FOREARM. X-RAYS TAKEN SHOW THAT THE STEM OF THE RADIAL HEAD WAS LOOSE. NO REVISION PROCEDURE HAS BEEN PLANNED AT THIS TIME. CONCOMITANT DEVICES: 18MM COCR RADIAL HEAD 2MM HT EXTENSION/13.5MM-STER (PART: 09.402.218S, LOT: 7607087, QUANTITY: 1) THIS REPORT IS FOR A 6MM TI STRAIGHT RADIAL STEM 24MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7588054 ↗
• InjuryApr 17, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2015, PATIENT WAS IMPLANTED WITH A RADIAL PROSTHESIS. ON (B)(6) 2018, THE IMPLANT WAS REMOVED DUE TO THE RADIAL STEM BECOMING LOOSE. IMPLANT WAS NOT REPLACED. THERE WAS NO REPORT OF PATIENT HARM. CONCOMITANT DEVICES REPORTED: 18MM COCR RADIAL HEAD STANDARD HEIGHT/11.5MM-STERILE (PART# 09.402.018S, LOT# 7838259, QUANTITY 1). THIS REPORT IS FOR ONE (1) 6MM TI STRAIGHT RADIAL STEM 24MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7437770 ↗

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