NA 04.402.010SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982128072), received between Apr 15, 2020 and Aug 6, 2020 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN ELBOW RADIAL HEAD REPLACEMENT SURGERY DUE TO THE LOOSENING OF THE RADIAL HEAD PROSTHESIS AS CONFIRMED THROUGH X-RAY ON AN UNKNOWN DATE. ON OR ABOUT (B)(6) 2016, THE PATIENT WAS IMPLANTED WITH A DEPUY SYNTHES RADIAL HEAD IMPLANT SYSTEM. POSTOPERATIVELY, PATIENT EXPERIENCED INCREASING PAIN, LOSS OF RANGE OF MOTION, WEAKNESS OF RIGHT ELBOW AND SURROUNDING REGIONS AND DECREASED FUNCTION OF THE ELBOW. IT WAS UNKNOWN IF THE SURGERY WAS COMPLETED SUCCESSFULLY WITH OR WITHOUT DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES ONLY. THIS REPORT IS FOR (1) 10MM TI STRAIGHT RADIAL STEM 32MM-STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10373835 ↗
• InjuryApr 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE: RECEIVED ADDITIONAL MEDICAL RECORDS REGARDING (B)(6) ((B)(4)).

  Patient problems: Hypoesthesia; Loss of Range of Motion; No Code Available; Pain

  MAUDE report 9964400 ↗

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