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REUNION 5569-P-2008Recalls & reported problems

Stryker GmbH · PRESS-FIT HUMERAL STEM · Class 2 · Implant

All models of REUNION (113)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327098099), received between Sep 11, 2020 and Sep 11, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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

Device problems

  • Fracture1

Patient problems

  • Failure of Implant1
  • Implant Pain1
  • Injury1
  • Loss of Range of Motion1
  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • 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 10525150 ↗

Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices

All PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices →

Sources and updates

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