NA 09.402.018SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982132574), received between Mar 14, 2019 and Feb 28, 2023 — classified as 3 injuries.

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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 28, 2023Device Slipped; Device Slipped

  THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Discomfort; Pain

  MAUDE report 16452295 ↗
• InjuryJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE DEVICE WAS EXPLANTED AND WAS FOUND TO BE GROSSLY LOOSE AND HAD DESTRUCTIVE PATTERN OF THE PROXIMAL RADIUS. ON (B)(6) 2016 THE PATIENT FELL, FRACTURING HER LEFT RADIAL HEAD AND HER CORONOID PROCESS. ON (B)(6) 2016 A DEPUY SYNTHES RADIAL HEAD PROSTHESIS WAS IMPLANTED. IN 2021, THE PATIENT DEVELOPED SIGNIFICANT PAIN AND HER PRIMARY CARE PHYSICIAN OBTAINED AN X-RAY ON (B)(6) 2021, THAT SHOWED THE STEM OF THE HARDWARE WAS WITH SURROUNDING LUCENCY OF INDETERMINATE CHRONICITY. THE PATIENT WAS THEN REFERRED TO AN ORTHOPEDIC SURGEON WHO OBTAINED A CT SCAN THAT SHOWED PERIHARDWARE LUCENCY ABOUT THE STEM OF THE ARTHROPLASTY HARDWARE MEASURING UP TO 2-3MM. THERE IS NO HARDWARE FRACTURE. HOWEVER, THERE IS COMPLETE BONE LOSS AT THE POSTERIOR ASPECT OF THE ARTHROPLASTY HARDWARE INVOLVING APPROXIMATELY 50% OF THE LENGTH OF THE STEM. THIS REPORT INVOLVES ONE (1) 18MM COCR RADIAL HEAD STANDARD HEIGHT/11.5MM-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 14715468 ↗
• InjuryMar 14, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A REMOVAL OF IMPLANT (DEEP) DUE TO LOOSENING AND PERIPROSTHETIC FRACTURE, AND ANCONEUS RATIONAL MYOPLASTY. A BRACHIAL PLEXUS ON-Q CATHETER WAS ALSO PLACED. AN INCISION WAS MADE OVER THE ANCONEOUS. THE FASCIA WAS INCISED OVER THE ANCONEOUS, PEDICLED IT OFF THE NEUROVASCULAR PEDICLE AND TOOK IT OFF THE ULNA. THE CAPSULED WAS ALSO INCISED. THE IMPLANT BASICALLY FELL OUT OF THE WOUND AND MULTIPLE CULTURE OF THE SCAR TISSUE WERE TAKEN. THE CAPITELLUM WAS EBURNATED. FLUOROSCOPY WAS PERFORMED BOTH IN VARUS-VALGUS AND AT THE DRUJ WAS STABLE. THE TOP OF ANCONEOUS WAS PEDICLE INTO THE JOINT AND THEN THE CAPSULE WAS CLOSED USING 2 MITEK G2 ANCHORS. THE ELBOW WAS STABLE AT THIS POINT. ON (B)(6) 2015, THE PATIENT WHO WAS MOUNTAIN CLIMBING IN AN INDOOR GYM WHEN SHE NOTED IMMEDIATE PAIN AND DISCOMFORT IN THE RIGHT ELBOW AFTER A FALL FROM ABOUT 15 FEET. THE PAIN WAS SEVERE, AND THE PATIENT FELT THAT HER ELBOW WAS OUT OF POSITION. ON (B)(6) 2015, RADIOGRAPHS SHOWED A COMMINUTED FRACTURE OF THE RADIAL HEAD WITH IMPACTION WITH SUBLUXED RADIAL HEAD. A CLOSED REDUCTION OF THE RIGHT ELBOW WAS PERFORMED. ON (B)(6) 2015, THE PATIENT UNDERWENT A RI

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 8422076 ↗

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