Shoulder System 04.01.0163Recalls & reported problems
Medacta International SA · Glenoid polyaxial locking screw - L38 · Class 2 · Implant
All models of Shoulder System (63)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040706506), received between May 25, 2018 and Dec 21, 2023 — classified as 1 injury, 2 malfunctions.
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
- Difficult to Remove1
Patient problems
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 21, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
THE PATIENT HAD PRIMARY SURGERY ON (B)(6) 2023. REVISION SURGERY DUE TO INFECTION WAS PERFORMED ON (B)(6) 2023. GLENOSPHERE AND LINER REVISED SUCCESSFULLY. ON (B)(6) 2023, THE PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION. THE SURGEON REVISED ALL THE COMPONENTS SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 18371303 ↗MalfunctionOct 9, 2018Break; Break
WHILE PERFORMING THE FINAL TIGHTENING OF THE SCREW, THE HEAD OF THE INNER SCREW BROKE OFF. THE SURGEON WAS ABLE TO RECOVER IT. THE SURGERY WAS COMPLETED SUCCESSFULLY AND WITHOUT DELAY.
Patient problems: Foreign Body In Patient
MAUDE report 7946595 ↗MalfunctionMay 25, 2018Difficult to Remove
DURING SCREWING, THE HEAD OF THE SCREW OPENED. AFTER THIS IT WAS IMPOSSIBLE TO UNSCREW IT OUT. SURGEON TOOK OUT THE INNER SMALL SCREW AND BROKE THE 4 FLAPS WITH A CLAMP, SO THE SCREW WAS DEEP ENOUGH FOR NO IMPINGEMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7544750 ↗
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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