Shoulder System 04.01.0206Recalls & reported problems
Medacta International SA · Lat. Glenosphere 32xØ24.5 · Class 2 · Implant
All models of Shoulder System (63)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630040728058), received between Mar 15, 2022 and Jul 14, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available1
- Device Appears to Trigger Rejection1
Patient problems
- Joint Laxity3
- Implant Pain1
- Medical device site infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO INSTABILITY AFTER ABOUT 1 MONTHS FROM PRIMARY. THE SURGEON REVISED THE D 32/+3 SMALL REVERSE LINER TO A D 36/+6 SMALL REVERSE LINER AND REVISED THE 32XD 24.5 GLENOSPHERE TO A 36XD 24.5 GLENOSPHERE.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 25813743 ↗InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AT ABOUT 3 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE INSERT WITH A THICKER ONE (FROM 11MM TO 13MM) AND RESURFACED THE NATIVE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Laxity
MAUDE report 18526032 ↗InjuryJan 11, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE GLENOSPHERE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 18493518 ↗InjuryMar 15, 2022Appropriate Device Problem Term/Code Not Available
AT 10 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE GLENOSPHERE AND LINER DUE TO INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Laxity
MAUDE report 13770429 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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