NA 09.402.622SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982132772), received between Mar 28, 2018 and Feb 7, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2023Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT BEGAN USING SYNTHES RADIAL HEAD PROSTHESIS SYSTEM. THE PRODUCT WAS DEFECTIVE BECAUSE THE IMPLANT WAS LOOSE. THE DEFECT CAUSED PAIN WITH ANY MOVEMENT, NUMBNESS IN HAND, SHAKY, ELBOW LOCKS UP AND HAS POPPED OPEN, AND THERE IS BONE LOSS AROUND THE IMPLANT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 22 COCR RADIAL HD 6 HT EXTENSION/18.5-S. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: Pain

  MAUDE report 16314382 ↗
• InjuryMay 16, 2018Break; Break

  IT WAS REPORTED THAT A HARDWARE REMOVAL PROCEDURE TOOK PLACE ON (B)(6) 2018 DUE TO THE LOOSENING OF A RADIAL HEAD PROSTHESIS STEM IMPLANT. THE PATIENT CAME TO THE EMERGENCY ROOM ON AN UNKNOWN DATE WITH UNKNOWN COMPLAINTS. IT WAS DURING THAT VISIT THAT AN X-RAY WAS TAKEN AND IT WAS DISCOVERED THAT THE RADIAL HEAD PROSTHESIS STEM WAS LOOSE. BOTH PARTS OF THE TWO-PIECE IMPLANT WERE REMOVED DURING THE (B)(6) PROCEDURE. THE X-RAY TAKEN IN THE EMERGENCY ROOM IS NOT AVAILABLE. THE HARDWARE REMOVAL PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFULLY WITH NO COMPLICATIONS. THE PATIENT WAS NOT REVISED TO ANYTHING BECAUSE HER FRACTURE WAS STABLE. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION FOLLOWING THE PROCEDURE. NO INFORMATION IS AVAILABLE ABOUT THE ORIGINAL IMPLANT PROCEDURE OF THE DEVICE. UPON MANUFACTURER'S INVESTIGATION OF RETURNED DEVICE, IT WAS NOTED THAT THE RETURNED STEM WAS RECEIVED WITH A STEM SCREW FROM THE RETURNED RADIAL HEAD IMPLANT EMBEDDED IN IT, WHICH DID NOT CONFIRM THE COMPLAINT CONDITION OF LOOSENING, BUT THE BROKEN STEM SCREW BEING JAMMED IN THE RETURNED HEAD WAS CONFIRMED. IT WAS NOTED THAT DUE TO THE BROKEN RADIAL HEAD SCREW BEING EMBEDDED IN THE RETURNED

  Patient problems: No Code Available

  MAUDE report 7519589 ↗
• InjuryMar 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT REMOVAL OF A RADIAL HEAD AND STEM PROSTHESIS ON (B)(6) 2018. THE REMOVAL WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM. THE PATIENT WAS NOT REVISED TO ANYTHING FOLLOWING THE PROCEDURE. IT IS UNKNOWN WHY THE DEVICES WERE REMOVED. IT WAS REPORTED THAT IT MAY HAVE BEEN DUE TO A PATIENT'S COMPLAINT OF PAIN. THIS REPORT INVOLVES 2 DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7379544 ↗

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