Shoulder System 04.01.0158Recalls & reported problems
Medacta International SA · Glenoid polyaxial locking screw - L18 · 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 07630040706452), received between Jul 22, 2025 and Jul 22, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Migration1
- Osseointegration Problem1
Patient problems
- Inadequate Osseointegration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 22, 2025Fracture; Osseointegration Problem; Migration; Fracture; Osseointegration Problem; Migration
AT ABOUT TWO MONTHS FROM PRIMARY RSA SURGERY WITH BONE GRAFT, THE PATIENT REPORTED TO EMERGENCY ROOM FOR PAIN TO THE SHOULDER. DURING XRAYS, THE ABDUCTION OF THE SHOULDER CAUSED SEVERE PAIN BUT IMPLANT SEEMED OK. TEN (10) DAYS AFTER THE XRAYS, PATIENT RETURNED TO EMERGENCY ROOM AGAIN FOR PAIN AND THE XRAYS SHOWED DISPLACED IMPLANTS AND BROKEN SCREW. ACCORDING TO THE INFORMATION RECEIVED FROM THE SURGEON, IT IS LIKELY THAT THE BONE GRAFT FAILED TO HEAL AND CAUSED THE IMPLANT TO FAIL. CURRENTLY, IT IS NOT KNOWN IF THE PATIENT UNDERWENT A REVISION SURGERY OR IF A REVISION SURGERY IS SCHEDULED BEACUSE THE PATIENT WAS REFERRED TO DIFFERENT, UNKNOWN, CENTER, AND THE SURGEON AND THE SALES REPRESENTATIVE DO NOT HAVE FURTHER INFORMATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22564637 ↗
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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