Shoulder System 04.01.0151Recalls & reported problems
Medacta International SA · Glenoid baseplate Ø24.5x15 · Class 2 · Implant
All models of Shoulder System (63)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630040706384), received between Mar 4, 2020 and Feb 24, 2025 — classified as 6 injuries.
The most frequently reported specific device problem is “Migration” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Migration2
- Appropriate Device Problem Term/Code Not Available1
- Device Dislodged or Dislocated1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Bone Fracture(s)3
- Pain2
- Joint Dislocation1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING THE SHOULDER SURGERY, DURING THE INSERTION OF THE TRIAL LINER AND AFTER IMPLANTATION OF STEM AND METAPHYSIS, IT WAS NOTICED A FRACTURE OF THE GLENOID BONE. THE CAUSE IS UNKNOWN, EVEN IF AN HYPOTHESIS IS THAT THE FRACTURE COULD OCCUR WHEN THE REDUCTION WAS DONE USING THE IMPLANT AND THE TRIAL STEM, OR WHEN THE STEM IMPLANT WAS PUT IN AND THE TRIAL LINER WAS ATTACHED. THE ALREADY IMPLANTED BASEPLATE (Ø24.5X15) WAS REPLACED TO A 27MM BASEPLATE AND FIXED WITH POLYAXIAL SCREWS IN ANTERIOR AND POSTERIOR HOLES. ON THE HUMERAL SIDE, DIAPHYSIS, REVERSE METAPHYSIS AND LINER WERE PLACED. THE GLENOSPHERE WAS REMOVED AND NEW GLENOSPHERE WAS NOT INSERTED. AFTER BONE UNION ABOUT 3 TO 6 MONTHS, NEW GLENOSPHERE WILL BE IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE TOTAL SURGERY TIME WAS 2 HOURS AND 10 MINUTES. THE DELAY TIME WAS 30 MINUTES. THE BONE QUALITY WAS SLIGHTLY POOR.
Patient problems: Bone Fracture(s)
MAUDE report 21446258 ↗InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2022. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A TORN ROTATOR CUFF AND THE CAUSE IS UNKNOWN. THE SURGEON CONVERTED THE PATIENT FROM ANATOMIC TO REVERSE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED GLENOID AND THE CAUSE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Bone Fracture(s)
MAUDE report 21355523 ↗InjuryAug 22, 2024Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration
REVISION SURGERY DUE TO DISSOCIATION BETWEEN THE BASEPLATE AND THE GLENOSPHERE AT 2 YEARS AND 1 MONTH FROM THE PRIMARY. X-RAYS SHOW UPWARD ECCENTRICITY OF THE GLENOSPHERE AND SIGNS OF METALLOSIS ON BOTH THE GLENOID AND HUMERAL SIDES. GLENOSPHERE GUIDE WAS NOT USED DURING THE PRIMARY SURGERY.
Patient problems: Joint Dislocation
MAUDE report 20037830 ↗InjuryDec 21, 2023Migration; Migration
PRIMARY SURGERY PERFORMED IN 2020. REVISION SURGERY WAS PERFORMED DUE TO PAIN. SIGNS OF EXTENSIVE METALLOSIS AND SIGNIFICANT BONE LOSS WERE FOUND DURING REVISION. THE GLENOID COMPONENT WAS FOUND TO BE MOBILIZED. THE SURGEON REMOVED THE PROSTHESIS AND PUT A TEMPORARY CEMENT SPACER TO LET THE BONE HEAL.
Patient problems: Pain
MAUDE report 18370935 ↗InjuryJun 7, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE GLENOID BONE FRACTURED DURING THE GLENOSPHERE THIGHTENING. RSA IMPLANTS WERE IMMEDIATELY REVISED WITH AN HSA.
Patient problems: Bone Fracture(s)
MAUDE report 17077623 ↗InjuryMar 4, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THE PATIENT CAME IN, 2 YEARS AND 2 MONTHS AFTER PRIMARY SURGERY, REPORTING PAIN. WHEN THE SURGEON TOOK AN X-RAY, IT WAS OBSERVED THAT THE BASEPLATE WAS TOO SUPERIOR AND LOOSE. THE CAUSE OF THE SUPERIOR AND LOOSE BASEPLATE IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, GLENOID BASEPLATE, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 9785500 ↗
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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