Glenoid Reconstruction System 04.01.0301Recalls & reported problems
Medacta International SA · GRS baseplate - Ø24.5x20 +3mm · Class 2 · Implant
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 07630345710307), received between Aug 14, 2025 and Mar 2, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (2 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.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration2
Patient problems
- Aseptic loosening2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 2, 2026Loss of Osseointegration
AT ABOUT 1 YEAR 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY AND THE CAUSE WAS LOOSE BASEPLATE DUE TO POOR BONE QUALITY. NO BONE GRAFT USED DURING THE PRIMARY. THE SURGEON REVISED THE GLENOID, REVERSE METAPHYSIS TO ANATOMIC METAPHYSIS AND A SENSITIN HUMERAL HEAD WAS PLACED DUE TO NICKEL ALLERGY REPORTED BY THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening
MAUDE report 24482019 ↗InjuryAug 14, 2025Loss of Osseointegration; Loss of Osseointegration
THE PATIENT HAD PAIN DUE TO A LOOSE BASEPLATE AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND 8 MONTHS POST PRIMARY THE SURGEON REVISED THE BASEPLATE, GLENOSPHERE, SCREWS, LINER AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening
MAUDE report 22803542 ↗
Other Shoulder Prosthesis, Reverse Configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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.
How reports and recalls are matched · Editorial policy · Report an error on this page