REUNION 5571-S-3208Recalls & reported problems
Stryker GmbH · X3 HUMERAL INSERT, STANDARD · 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 07613327098426), received between Oct 19, 2020 and Oct 19, 2023 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Migration1
Patient problems
- Erythema1
- Fever1
- Implant Pain1
- Insufficient Information1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 19, 2023Migration; Migration
THIS IS A LEGAL CASE BEING REPORTED. THIS PRODUCT INQUIRY IS FOR THE REVISION SURGERY DUE TO IMPLANTS 'COMING APART/ SHIFTING' IN (B)(6) 2022. ANOTHER PRODUCT INQUIRY WAS OPENED FOR THE SCREW BREAKAGE. AS REPORTED: "PATIENT CALLED STATING HE HAD A SHOULDER REPLACEMENT IN (B)(6) 2021. IN (B)(6) 2022, A REVISION WAS NEEDED DUE TO A BROKEN SCREW. IN (B)(6) OF 2022, A TOTAL SHOULDER REVISION WAS NEEDED BECAUSE THE SHOULDER 'CAME APART/ SHIFTED."
Patient problems: Insufficient Information
MAUDE report 17969666 ↗InjuryOct 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "SUBJECT, CAME IN LAST WEEK ON 9/17 COMPLAINING OF PAIN AND REDNESS IN THE SHOULDER AS WELL AS A FEVER. AFTER DRAWING A SMALL AMOUNT OF CLOUDY FLUID, [SURGEON] SENT HER IMMEDIATELY TO THE ER AND HAD HER ADMITTED FOR A DEBRIDEMENT AND WASHOUT. SITE COORDINATOR HAS NOT SEEN THE RESULTS OF THE CULTURES YET, BUT SIGNS POINT TO INFECTION PER THE OPERATIVE REPORT AND CLINIC NOTE. [SURGEON] REMOVED AND EXCHANGED ALL HUMERAL COMPONENTS AS WELL AS THE GLENOSPHERE. HE LEFT THE ORIGINAL BASEPLATE. HE EXCHANGED THE OLD REUNION COMPONENTS WITH OTHER REUNION COMPONENTS."
Patient problems: Erythema; Fever; Implant Pain; Unspecified Infection
MAUDE report 10701779 ↗
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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