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REUNION 5552-S-5628Recalls & reported problems

Stryker GmbH · SR STANDARD HUMERAL HEAD · Class 2 · Implant

All models of REUNION (113)

Data updated Oct 18, 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 07613327097894), received between Aug 7, 2018 and Aug 7, 2018 — 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 18, 2026.

Most reported problems

Device problems

  • Device Dislodged or Dislocated1

Patient problems

  • Failure of Implant1

Recent adverse event reports

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

  • InjuryAug 7, 2018Device Dislodged or Dislocated

    IT WAS REPORTED THAT PATIENT'S LEFT SHOULDER WAS REVISED DUE TO THE HUMERAL HEAD BECOMING DISASSOCIATED FROM THE STEM. THE STEM WAS REPORTED TO HAVE COUNTER-SUNK INTO THE PATIENT'S HUMERUS. THE SURGEON STATED THAT NO TRAUMA (FALL, ETC) HAD BEEN REPORTED BY THE PATIENT. PATIENT WAS REVISED TO A LARGER STEM AND SAME-SIZED HUMERAL HEAD.

    Patient problems: Failure of Implant

    MAUDE report 7756239 ↗

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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