Shoulder System 04.01.0167Recalls & reported problems
Medacta International SA · Glenoidsphere 32xØ22 · Class 2 · Implant
All models of Shoulder System (63)
Data updated Oct 16, 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 07630040706544), received between Mar 24, 2020 and Mar 10, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
- Device Dislodged or Dislocated2
Patient problems
- Joint Dislocation1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 10, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE WHICH WAS OCCURRED WHEN THE PATIENT HAD A MUSCLE SPASM. 2 MONTHS AFTER PRIMARY THE SURGEON REVISED THE GLENOSPHERE, METAPHYSIS, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON REVISED THE METAPHYSIS ONLY TO OBTAIN ROOM TO ACCESS THE GLENOID FOR REMOVAL.
Patient problems: Pain
MAUDE report 11451744 ↗InjuryMar 24, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE POLY FROM THE GLENOSPHERE. THE DISLOCATION WAS DUE TO THE PATIENT REACHING FOR AN OBJECT. THE SURGEON REVISED THE GLENOSPHERE, HUMERAL REVERSE METAPHYSIS AND HUMERAL REVERSE HC LINER 1 MONTHS AND 8 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 9870996 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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