Shoulder System 04.01.0168Recalls & reported problems
Medacta International SA · Glenoidsphere 36xØ22 · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630040706551), received between Jun 13, 2018 and Jan 28, 2021 — classified as 1 injury, 1 malfunction.
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
- Device Dislodged or Dislocated2
- Scratched Material1
Patient problems
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2021Device Dislodged or Dislocated
REVISION SURGERY PERFORMED AFTER 1 YEAR AND 2 MONTHS FROM THE PRIMARY SURGERY DUE TO GLENOSPHERE SCREW DISASSOCIATION AND DISASSOCIATION OF THE GLENOSPHERE FROM THE BASPELATE. DURING THE REVISION SURGERY, THE BASEPLATE LOCKING SCREWS WERE RETIGHTENING DURING THE REVISION SURGERY. NO PROBLEMS OF THE BASEPLATE LOCKING SCREWS WERE REPORTED. GLENOSPHERE AND HC LINER WERE REPLACED WITH THE NEW ONES.
Patient problems: Insufficient Information
MAUDE report 11242689 ↗InjuryJun 13, 2018Device Dislodged or Dislocated; Scratched Material
REVISION 3 MONTHS AFTER PRIMARY DUE TO RECURRENT DISLOCATIONS; PRIMARY SURGERY PERFORMED ON (B)(6) 2018. THE SURGEON REVISED THE 36/0 LINER (IN POSITION 145°) WITH A 36/+3 LINER (IN POSITION 155°) TO OBTAIN A GOOD STABILITY. HE ALSO REVISED THE GLENOSPHERE AS IT HAD A SLIGHT SCRATCH.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7596016 ↗
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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