Shoulder System 04.01.0199Recalls & reported problems
Medacta International SA · Glenoid Polyaxial non-locking screw – L34 · Class 2 · Implant
All models of Shoulder System (63)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040719926), received between Oct 9, 2020 and Oct 9, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
- Unintended Movement1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 9, 2020Break; Unintended Movement
THE BASEPLATE SCREW BROKE AFTER THE PRIMARY SURGERY (PERFORMED ON (B)(6) 2020), AND THE BASEPLATE AND GLENOSPHERE MOBILIZED, IT IS POSSIBLE THAT THE SCREW BROKE DURING THE REHABILITATION. THE PATIENT HAS GOT AN MSS SHORT STEM REVERSE WITH BONE-GRAFT DURING THE PRIMARY SURGERY. IF EVERYTHING REMAINS AS IT IS NOW, THE PATIENT WILL NOT BE REVISED. IF THE X-RAY IMAGE WILL SHOW A DETERIORATION, THE REVISION WILL BE MADE. THE PROSTHESIS IS NOT LUXATED. THE PATIENT HAS NO PAIN AND IS DOING WELL. IN THIS TIME A REVISION SURGERY IS NO PLANNED, IN THE NEXT TWO WEEKS, THE PATIENT WILL HAVE A CONTROL VISIT.
Patient problems: Insufficient Information
MAUDE report 10655595 ↗
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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