Shoulder System 04.01.0210Recalls & reported problems
Medacta International SA · Lat. Glenosphere 36xØ27 · Class 2 · Implant
All models of Shoulder System (63)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040728096), received between Jul 10, 2025 and Jul 10, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Damaged Thread” (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
- Damaged Thread1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2025Damaged Thread; Damaged Thread
DURING TSA THE WHILE THE GLENSPHERE SEEMED CORRECTLY SEATED THE GLENOSPHERE SCREW GOT STUCK DURING INSERTION AND COULD NOT BE SCREWED IN, EVEN USING THE DEDICATED GLENOSPHERE GUIDE. THE SURGEON ALSO TRIMMED THE BONE AROUND THE BASEPLATE AND ATTEMPTED TO INSERT THE SCREW AGAIN TO NO AVAIL. A NEW SCREW WAS OPENED BUT ALSO THE SECOND SCREW COULD NOT BE SEATED. THE SURGEON THEN DECIDED TO CHANGE THE GLENOSPHERE WITH A NEW ONE, NOT HAVING ONE OF THE SAME REF IMPLANTED A STD. GLENOSPHERE 39XØ27 (REF. 04.01.0173). 45 MINUTES OF DELAY OVER A 4.5 HOURS SURGERY WERE REPORTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22467162 ↗
Other Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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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