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REUNION 5901-1116Recalls & reported problems

Stryker GmbH · Baseplate Holder · Class 2

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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327100273), received between Jul 15, 2020 and Jul 15, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 Difficult to Setup or Prepare1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJul 15, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

    AS REPORTED: "DURING LAST IMPACTION OF IMPLANT BASEPLATE, WE NOTICED IMPACTOR WAS FULLY EXTENDED WITHOUT RETURNING TO NORMAL WIDTH. THE SURGEON JUST LOOSENED THE BOLT AND PRESSED DOWN ON MOVEABLE TOOTH FOR EXTRACTION. PATIENT WAS NOT HARMED, NOR DID THIS ADD ANY ADDITIONAL TIME TO CASE."

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

    MAUDE report 10277747 ↗

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

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Sources and updates

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