REUNION 5571-C-3206Recalls & 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
- 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 07613327098563), received between Jul 5, 2023 and Jul 5, 2023 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Bone Fracture(s)2
- Loss of Range of Motion1
- Osteopenia/ Osteoporosis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REUNION RSA STUDY: (B)(4). PATIENT FELT A POP 7 WEEKS POST-OP AND CAME IN. IMAGES SHOWED STRESS FRACTURE AT BASE OF ACROMION W/O SUBSTANTIAL DISPLACEMENT. SHE DOES HAVE OSTEOPOROSIS WHICH MAY HAVE CONTRIBUTED. ACTIONS TAKEN: SLING WITH LIMITED MOBILITY. RESOLVED WITH SEQUELAE: (B)(6) 2021.
Patient problems: Bone Fracture(s); Loss of Range of Motion; Osteopenia/ Osteoporosis
MAUDE report 17256864 ↗InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
POST-MARKET CLINICAL EVALUATION OF THE REUNION REVERSE SHOULDER ARTHROPLASTY (RSA) SYSTEM: SUBJECT 02-067 DESCRIPTION OF THE EVENT: ACROMIAL STRESS REACTION ACTIONS TAKEN: SLING FOR TWO WEEKS RESOLVED WITH SEQUELAE: 17.AUG.2021.
Patient problems: Bone Fracture(s)
MAUDE report 17255069 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page