REUNION 5901-E-5223Recalls & reported problems
Stryker GmbH · Single Radius 4mm Offset Humeral Head Trial · Class 1
All models of REUNION (113)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327099928), received between Jun 21, 2018 and Apr 11, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
- Component Missing1
- Detachment of Device or Device Component1
- Device Inoperable1
- Naturally Worn1
- Out-Of-Box Failure1
Patient problems
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2019Break; Component Missing; Detachment of Device or Device Component; Naturally Worn
UPON INCOMING INSPECTION, ITEM WAS VISIBLY WORN. INVESTIGATION OF THE DEVICE REVEALED THAT THE INNER PEGS WERE BROKEN OFF AND MISSING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8503031 ↗MalfunctionJun 21, 2018Break; Device Inoperable; Out-Of-Box Failure
UPON INCOMING INSPECTION, IT WAS NOTICED THAT THE DEVICE WAS BROKEN AND UNUSABLE. INNER PLASTIC PEG WAS BROKEN AND MISSING.
Patient problems: No Patient Involvement
MAUDE report 7627541 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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