NA 09.402.220SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982132642), received between Apr 16, 2019 and Apr 16, 2019 — classified as 1 injury.

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

• InjuryApr 16, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT HAD A RIGHT ELBOW AND RIGHT FOREARM REMOVAL OF HEADWARE DUE TO CHRONIC RIGHT WRIST PAIN, WITH PAINFUL RETAINED HARDWARE OF THE RIGHT FOREARM AND RIGHT ELBOW. WHICH IS THE IMPLANT WAS NOTED TO BE APPRECIABLY LOOSE. ON (B)(6) 2015, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE MIDSHAFT ULNA AND RADIAL HEAD REPLACEMENT USING A SYNTHES RADIAL HEAD/STEM AFTER THE MOTOR VEHICULAR ACCIDENT (MVA) ON (B)(6) 2015. ON (B)(6) 2018, THE PATIENT EXPERIENCE RIGHT ELBOW PAIN AND SWELLING. THE PATIENT EXPERIENCE LUCENCY AROUND THE IMPLANT AROUND THE STEM OF THE RADIAL HEAD ARTHROPLASTY. ASEPTIC LOOSENING OF THE IMPLANTS IS A KNOWN COMPLICATION OF THE RADIAL HEAD IMPLANTATION AND GIVEN THE COMMINUTED NATURE OF THE TRAUMA IN 2015 RADIAL HEAD ARTHROPLASTY WAS INDICATED. THE X-RAY RESULT ON (B)(6) 2018, THE RIGHT ELBOW MULTIPLE CASSETTES DEMONSTRATE SIGNIFICANT INSTABILITY OF THE RADIAL HEAD SHAFT COMPONENT, WITH SUBSTANTIAL WALLOWING. ON (B)(6) 2018, THE PATIENT STATES THAT THE SWELLING CAME BACK OVER THE WEEKEND AND IT IS GETTING A CATCHING FEELING IN THE ELBOW AND THE WRIST. THE PATIENT DESCRIBES THE PAIN AS FATIGUE. ON (B)(6) 2

  Patient problems: Hypoesthesia; Loss of Range of Motion; Pain

  MAUDE report 8518783 ↗

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