RHEAD RHA-S2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00886385024721), received between May 8, 2018 and Aug 8, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (1 report).

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.

• InjuryAug 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED THAT FIVE MONTHS POST LEFT RADIAL HEAD ARTHROPLASTY FOR COMMINUTED RADIAL HEAD FRACTURE THEY DEVELOPED INCREASING PAIN AND LOSS RANGE OF MOTION. SURGEONS FOUND PATIENT HAD A GROSSLY RADIAL HEAD IMPLANT WHEN WEIGHT BEARING OF THE RENAL STEM. PATIENT HAD CLOSE TO ZERO PRONATION AND SUPINATION AND LACKING 20 DEGREES EXTENSION. X-RAYS AND REVISION SURGERY CONCLUDED THESE FINDINGS. A SECOND REVISION WAS NEEDED 10 MONTHS AFTER INITIAL SURGERY. THE FIRST REVISION IS CAPTURED ON MFR REPORT # 0008031020-2021-00328.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 12292206 ↗
• InjuryJul 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED THAT FIVE MONTHS POST LEFT RADIAL HEAD ARTHROPLASTY FOR COMMINUTED RADIAL HEAD FRACTURE THEY DEVELOPED INCREASING PAIN AND LOSS RANGE OF MOTION. SURGEONS FOUND PATIENT HAD A GROSSLY RADIAL HEAD IMPLANT WHEN WEIGHT BEARING OF THE RENAL STEM. PATIENT HAD CLOSE TO ZERO PRONATION AND SUPINATION AND LACKING 20 DEGREES EXTENSION. X-RAYS AND REVISION SURGERY CONCLUDED THESE FINDINGS. REVISION SURGERY WAS NEEDED 5 MONTHS AFTER INITIAL SURGERY.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 12249540 ↗
• InjuryMay 8, 2018Failure To Adhere Or Bond

  PATIENT CALLED AND STATED THAT HE HAD A ELBOW REPLACEMENT DONE ON (B)(6) 2017. ON OR ABOUT (B)(6) 2018 HE STARTED EXPERIENCING PAIN IN HIS ELBOW. HE WENT TO HIS DOCTOR AND HAD X-RAYS AND WAS TOLD THAT THE IMPLANT HAD LOOSENED AND NEEDS TO BE REPLACED. PATIENT IS ALSO INQUIRING ABOUT RECALL.

  Patient problems: Pain

  MAUDE report 7493794 ↗