Shoulder System 04.01.0117Recalls & reported problems
Medacta International SA · Humeral Reverse HC Liner Ø32/+3mm · 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
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630040706247), received between Mar 19, 2025 and May 28, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated4
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Implant Pain2
- Joint Dislocation2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMay 28, 2026Device Dislodged or Dislocated
AT ABOUT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A DISLOCATION OF THE LINER AND GLENOSPHERE AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA.THE SURGEON REVISED THE LINER WITH ANOTHER ONE OF THE SAME SIZE AND REVISED THE METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 25313927 ↗InjuryOct 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT CAME IN DUE TO PAIN ASSOCIATED WITH A JOINT LUXATION AND THE CAUSE IS UNKNOWN. ABOUT 3 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON UPSIZED THE METAPHYSIS, LINER, AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 23310525 ↗InjuryJul 11, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
ONE MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE DUE TO EXCESSIVE OFFSET IN PRIMARY. THE SURGEON REVISED THE GLENOSPHERE AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 22479552 ↗InjuryMar 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FOR THE GLENOSPHERE. ABOUT 1 MONTH AFTER THE SURGERY, THE SURGEON REVISED THE DIAPHYSIS, LINER AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 21642694 ↗
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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