REUNION 5552-E-4416Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327097900), received between Sep 11, 2020 and Dec 4, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionDec 4, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING A PRIMARY RIGHT SHOULDER PROCEDURE, THE HUMERAL HEAD WAS OPENED AND A POWDER SUBSTANCE WAS OBSERVED IN THE TRAY AND ON THE IMPLANT. A SECOND IMPLANT WAS OPENED AND THE SAME ISSUE WAS OBSERVED. THE FIRST IMPLANT (LOT XM3373) WAS CLEANED OFF AND IMPLANTED. SURGERY WAS COMPLETED SUCCESSFULLY WITH ABOUT A 3 MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10946201 ↗
• InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT IS EXPERIENCING PAIN AND NUMBNESS IN THE RIGHT LATERAL ARM, FOREARM, AND HAND AND IS UNABLE TO FLEX RIGHT ELBOW. PATIENT REPORTS THAT THE SYMPTOMS OCCURRED AFTER THE PAIN CATHETER WAS REMOVED. NERVE CONDUCTION STUDY PERFORMED ON (B)(6) 2020 INDICATES "ACUTE RIGHT BRACHIAL PLEXOPATHY AFFECTING ALL PARTS OF THE BRACHIAL PLEXUS, BUT MOST SIGNIFICANTLY, THE UPPER TRUNK."

  Patient problems: Implant Pain; Loss of Range of Motion; Numbness

  MAUDE report 10672229 ↗
• InjurySep 11, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT HAD HER LEFT SHOULDER REPLACED ON OR ABOUT (B)(6) 2014 DUE TO OSTEOARTHRITIS. IT IS ALLEGED THAT THIS RESULTED IN PAIN IN THE SHOULDER AND SURROUNDING REGIONS, LOSS OF RANGE OF MOTION AND A FRACTURE OF THE COMPONENTS. IT IS FURTHER ALLEGED THAT THE PATIENT WAS REVISED ON (B)(6) 2019 AND DURING THE SURGERY THE SURGEON FOUND THE POLYETHYLENE GLENOID TO BE COMPLETELY FRACTURED DOWN THE MIDDLE.

  Patient problems: Failure of Implant; Implant Pain; Injury; Loss of Range of Motion; Pain

  MAUDE report 10525159 ↗