Shoulder System 04.01.0212Recalls & reported problems
Medacta International SA · Lat. Glenosphere 42xØ27 · 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 07630040728119), received between Oct 14, 2021 and Mar 10, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 Dislocated3
- Adverse Event Without Identified Device or Use Problem1
- Migration1
Patient problems
- Joint Dislocation2
- Joint Laxity1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMar 10, 2026Device Dislodged or Dislocated
AT 1 YEAR AND 4 MONTHS FROM THE PATIENT CAME IN PRESENTING PAIN DUE TO A DISLOCATION OF THE GLENOSPHERE AND LINER. THERE WAS NO REPORTED TRAUMA AS A CAUSE. THE SURGEON REVISED THE METAPHYSIS, GLENOSPHERE AND LINER TO A CONSTRAINED LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 24558206 ↗InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AT 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO INSTABILITY WITH THE CAUSE UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, METAPHYSIS, AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Laxity
MAUDE report 22931756 ↗InjuryJan 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ABOUT 6 WEEKS AFTER THE PRIMARY SURGERY, THE X-RAYS SHOWED THAT THE GLENOSPHERE WAS PARTIALLY DISSOCIATED FROM THE BASEPLATE DUE TO GLENOSPHERE SCREW UNSCREWING. THE PATIENT HAD NO SYMPTOMS. REVISION SURGERY HAS BEEN PERFORMED, GLENOSPHERE AND GLENOSPHERE SCREW REVISED. GLENOSPHERE GUIDE WAS NOT USED DURING THE PRIMARY SURGERY.
Patient problems: Joint Dislocation
MAUDE report 21251764 ↗InjuryOct 14, 2021Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration
AT 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND A GRINDING FEELING IN THE SHOULDER. THE SURGEON TOOK X-RAYS AND IT WAS DETERMINED THAT GLENOSPHERE SCREW AND IMPLANT WERE LOOSE. THE SURGEON REVISED THE LATERALIZED GLENOSPHERE AND THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 12631996 ↗
Other Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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.
How reports and recalls are matched · Editorial policy · Report an error on this page