Shoulder System 04.01.0118Recalls & reported problems
Medacta International SA · Humeral Reverse HC Liner Ø32/+6mm · Class 2 · Implant
All models of Shoulder System (63)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630040706254), received between Jul 30, 2019 and Dec 20, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 Dislocated5
Patient problems
- Joint Dislocation3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN FROM PAIN ASSOCIATED WITH A DISLOCATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER WITH A CONSTRAINED LINER OF THE SAME SIZE TO ADDRESS THE DISLOCATIONS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 23858463 ↗InjurySep 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AFTER DISLOCATING ANTERIORLY DURING PHYSICAL THERAPY AFTER THE PT PULLED ON THE ARM. THE SURGEON REVISED THE POLY AND METAPHYSIS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 17773090 ↗InjuryJul 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE WAS UNKNOWN. ABOUT 5 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER, GLENOSPHERE, AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17387717 ↗InjuryNov 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION SURGERY PERFORMED AT ABOUT 8 MONTHS AFTER THE PRIMARY DUE TO JOINT LUXATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE METAPHYSIS AND THE LINER.
Patient problems: Pain
MAUDE report 15779261 ↗InjuryJul 30, 2019Device Dislodged or Dislocated
THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A DISLOCATION OF THE LINER FROM GLENOSPHERE. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON CLOSED REDUCED THE PATIENT 1 MONTH AND A HALF AFTER PRIMARY AND NO IMPLANTS WERE REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 8841032 ↗
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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