REUNION 5542-K-0040Recalls & reported problems
Stryker GmbH · X3 KEELED GLENOID · Class 2 · Implant
All models of REUNION (113)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327097702), received between Oct 13, 2020 and Apr 28, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration” (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
- Adverse Event Without Identified Device or Use Problem1
- Migration1
Patient problems
- Failure of Implant1
- Implant Pain1
- Loss of Range of Motion1
- Numbness1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 28, 2021Migration; Migration
IT WAS REPORTED THAT THE SUBJECT PRESENTED WITH A LOOSE GLENOID COMPONENT 1 YEAR POST-OP. AT THE TIME OF THE REPORT AN ARTHROSCOPY AND DEBRIDEMENT WAS PLANNED.
Patient problems: Failure of Implant
MAUDE report 11739606 ↗InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "PATIENT IS EXPERIENCING PAIN AND NUMBNESS IN THE RIGHT LATERAL ARM, FOREARM, AND HAND AND IS UNABLE TO FLEX RIGHT ELBOW. PATIENT REPORTS THAT THE SYMPTOMS OCCURRED AFTER THE PAIN CATHETER WAS REMOVED. NERVE CONDUCTION STUDY PERFORMED ON (B)(6) 2020 INDICATES "ACUTE RIGHT BRACHIAL PLEXOPATHY AFFECTING ALL PARTS OF THE BRACHIAL PLEXUS, BUT MOST SIGNIFICANTLY, THE UPPER TRUNK."
Patient problems: Implant Pain; Loss of Range of Motion; Numbness
MAUDE report 10672175 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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