Shoulder System 04.01.0172Recalls & reported problems
Medacta International SA · Glenoidsphere 36xØ27 · Class 2 · Implant
All models of Shoulder System (63)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630040706599), received between Jan 10, 2020 and Mar 26, 2025 — classified as 8 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Appropriate Device Problem Term/Code Not Available2
- Device Dislodged or Dislocated2
- Fracture1
- Migration1
Patient problems
- Bone Fracture(s)3
- Joint Dislocation2
- Failure of Implant1
- Loss of Range of Motion1
- Medical device site infection1
- Toxicity1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACROMIAL STRESS FRACTURE OCCURRED APPROXIMATELY 3 MONTHS POST-PRIMARY SURGERY. THE PATIENT HAS NOT BEEN REVISED, THE SURGEON OPTED FOR A CONSERVATIVE TREATMENT. THE PATIENT HAS SIGNIFICANT RHEUMATOID AND OSTEOARTHRITIS, AND ALMOST COMPLETE OBLITERATION OF THE GLENOHUMERAL JOINT.
Patient problems: Bone Fracture(s)
MAUDE report 21695694 ↗InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACROMIAL STRESS FRACTURE OCCURRED APPROXIMATELY 3 MONTHS POST SURGERY. THE PATIENT HAS NOT BEEN REVISED, THE SURGEON OPTED FOR A CONSERVATIVE TREATMENT.
Patient problems: Bone Fracture(s)
MAUDE report 21547427 ↗InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO INFECTION PERFORMED ABOUT 1 MONTH AFTER THE PRIMARY SURGERY. GLENOSPHERE AND LINER REVISED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 18281373 ↗InjuryDec 6, 2023Migration; Migration
AT 3 YEARS AND 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND A LIMITED RANGE OF MOTION DUE TO DISSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE. THE CAUSE OF THE DISSOCIATION IS UNKNOWN. THE SURGEON REVISED THE LINER AND GLENOSPHERE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE ARE SCREW RING MARKS ON THE BACK SIDE OF THE GLENOSPHERE, AND TWO POLYAXIAL SCREW HEADS WERE ALSO FOUND TO BE DAMAGED. A MILD DEGREE OF METALLOSIS WAS ALSO OBSERVED.
Patient problems: Loss of Range of Motion
MAUDE report 18272871 ↗InjuryJun 28, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
AT ABOUT 4 MONTHS AFTER THE PRIMARY, REVISION OF METHAPHYSIS, GLENOSPHERE, AND LINER FOLLOWING SHOULDER LUXATION . THE DEFICIT OF THE MUSCLE-TENDON COMPLEX, LINKED TO INACTIVITY AND MASS, MAY HAVE REDUCED JOINT STABILITY.
Patient problems: Joint Dislocation
MAUDE report 14839514 ↗InjuryAug 3, 2021Device Dislodged or Dislocated
REVISION SURGERY PERFORMED 5 MONTHS AFTER PRIMARY FOLLOWING INSTABILITY AND LUXATION (GLENOSPHERE DISLOCATED FROM THE LINER). THE GLENOSPHERE WAS CHANGED FROM A 36 TO A 39 TO PROVIDE MORE STABILITY. THE PATIENT IS IN A WHEELCHAIR AND IS AFFECTED BY MULTIPLE SCLEROSIS.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 12266810 ↗InjuryJun 25, 2021Fracture
PRIMARY SURGERY PERFORMED IN (B)(6) 2021. FRACTURE OF THE ACROMION DETECTED 1 MONTH AFTER THE SURGERY. NO REVISION SURGERY SCHEDULED AT THIS TIME.
Patient problems: Bone Fracture(s)
MAUDE report 12067299 ↗InjuryJan 10, 2020Appropriate Device Problem Term/Code Not Available
ABOUT 7 MONTHS AFTER PRIMARY REVISION SURGERY PERFORMED DUE TO DISSOCIATION OF THE GLENOSPHERE FROM THE GLENOID BASEPLATE, DURING THE REVISION SURGERY METALLOSIS HAS BEEN DISCOVERED. THE GLENOSPHERE, AND THE HUMERAL REVERSE HC LINER HAVE BEEN REPLACED WITH NEW IMPLANTS, THE GLENOID BASEPLATE WAS LEFT IN PLACE.
Patient problems: Toxicity
MAUDE report 9574062 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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