Shoulder System 04.01.0160Recalls & reported problems
Medacta International SA · Glenoid polyaxial locking screw - L26 · Class 2 · Implant
All models of Shoulder System (63)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630040706476), received between Mar 8, 2019 and Mar 13, 2026 — classified as 3 injuries, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Device Appears to Trigger Rejection1
- Material Deformation1
- Material Fragmentation1
Patient problems
- Joint Impingement1
- Medical device site infection1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMar 13, 2026Break
APPROXIMATELY 1 YEAR AND 3 MONTHS AFTER THE PRIMARY SURGERY, X-RAYS CLEARLY SHOWED THE BREAKAGE OF ONE GLENOID SCREW. A REVISION SURGERY HAS BEEN SCHEDULED BUT HAS NOT YET BEEN PERFORMED.
Patient problems: Joint Impingement
MAUDE report 24588555 ↗InjuryOct 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AFTER 3 YEARS 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE GLENOID TO A LATERAL GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO INFORMATION ON THE GLENOSPHERE ARE AVAILABLE.
Patient problems: Medical device site infection
MAUDE report 23347367 ↗InjuryMay 3, 2024Material Deformation; Material Deformation
THE PRONGS OF THE GLENOID POLYAXIAL LOCKING SCREW DEFORMED DURING INSERTION. THE SURGEON HAD TO CUT OFF THE HEAD AND LEAVE THE BROKEN SCREW INSIDE THE PATIENT'S BONE TO COMPLETE THE SURGERY. BONE WAS VERY HARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19237810 ↗MalfunctionMar 8, 2019Material Fragmentation; Material Fragmentation
THE SURGEON MAY HAVE MISPLACED THE SCREW DURING SURGERY AND THE HEAD OF THE SCREW BROKE. HE DECIDED TO USE ANOTHER SCREW TO COMPLETE THE CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8403057 ↗
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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