REUNION 5901-C-3202Recalls & reported problems
Stryker GmbH · Glenosphere Trial Concentric · Class 2
All models of REUNION (113)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327100457), received between Jun 21, 2018 and Mar 4, 2020 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (3 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 18, 2026.
Most reported problems
Device problems
- Break3
- Fracture2
- Component Missing1
- Detachment of Device or Device Component1
- Naturally Worn1
Patient problems
- No Known Impact Or Consequence To Patient6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2020Fracture; Fracture
IT WAS REPORTED: 32X2MM GLENOSPHERE TRIAL BROKE WHEN BEING REMOVED FROM BASEPLATE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9788031 ↗MalfunctionNov 14, 2019Fracture; Fracture
AS REPORTED: "DOCTOR WAS TRIALING GLENOSPHERE AND TRIED TO REMOVE IT WITH FORCEPS. IT WOULD NOT COME OFF BASEPLATE. HE THEN REMOVED IT WITH AN OSTEOTOME, BREAKING THE TRIAL GLENOSPHERE".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9323875 ↗MalfunctionSep 3, 2019Naturally Worn
UPON INCOMING INSPECTION, ITEMS WERE VISIBLY WORN. NO ASSOCIATED PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8958196 ↗MalfunctionDec 27, 2018Break
WHEN DOING REUNION REVERSE SHOULDER NOTICED GLENOSPHERE TRIAL WAS BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8200430 ↗MalfunctionDec 10, 2018Break
AS REPORTED BY REP: "DOING A REVERSE SHOULDER ARTHROPLASTY. DOCTOR REMOVED TRIAL GLENOSPHERE AND EDGE OF TRIAL BROKE DURING REMOVAL".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8148417 ↗MalfunctionJun 21, 2018Break; Component Missing; Detachment of Device or Device Component
DEVICE WAS BROKEN AND UNUSABLE. SMALL PIECE OF THE DEVICE REVEALED TO BE BROKEN OFF AND MISSING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7627608 ↗
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- 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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