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REUNION 5571-C-3608Recalls & reported problems

Stryker GmbH · X3 HUMERAL INSERT, CONSTRAINED · 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 07613327098624), received between Mar 29, 2019 and Mar 29, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

  • Device Dislodged or Dislocated1

Patient problems

  • Bone Fracture(s)1
  • Joint Dislocation1
  • No Code Available1

Recent adverse event reports

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

  • InjuryMar 29, 2019Device Dislodged or Dislocated

    SURGEON REPORTED THAT LEFT REVERSE SHOULDER REPLACEMENT DUE TO A FRACTURE HAS SUBLUXED AND DISLOCATED. CT SCAN SHOWED LARGE AMOUNT OF FLUID IN THE JOINT. SURGEON DECIDED TO REVISE THE SHOULDER, EVACUATE AND THE FLUID. HE INCREASED THE TENSION WITH INCREASED GLENIOSPHERE OFFSET AND THICKER CUP AND LINER. THE SHOULDER APPEARED STABLE AND THE SURGERY WAS PERFORMED WITHOUT INCIDENT.

    Patient problems: Bone Fracture(s); Joint Dislocation; No Code Available

    MAUDE report 8466015 ↗

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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