Shoulder System 04.01.0156Recalls & reported problems
Medacta International SA · Glenoid baseplate Ø27x35 · Class 2 · Implant
All models of Shoulder System (63)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040706438), received between Aug 31, 2022 and Jun 17, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).
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 Problem1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Osseointegration Problem1
Patient problems
- Bone Fracture(s)1
- Inadequate Osseointegration1
- Inflammation1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem
POSTOPERATIVE ACROMION FRACTURE OCCURRED APPROXIMATELY 5 MONTHS AFTER THE PRIMARY SURGERY. THE PATIENT IS BEING TREATED CONSERVATIVELY.
Patient problems: Bone Fracture(s)
MAUDE report 25528751 ↗InjuryJul 11, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY PERFORMED ABOUT 10 MONTHS AFTER THE PRIMARY SURGERY DUE TO GLENOID COMPONENT LOOSENING. THE PATIENT WAS REVISED TO A HEMI. BONE GRAFT USED IN THE PRIMARY.
Patient problems: Insufficient Information
MAUDE report 17297390 ↗InjuryAug 31, 2022Osseointegration Problem; Osseointegration Problem
REVISION SURGERY AT ABOUT 1 YEAR AND 4 MONTHS AFTER THE PREVIOUS REVISION SURGERY, OF NON MEDACTA COMPONENTS (WHICH WAS REPLACED BY NICKELFREE MEDACTA REVERSE PRODUCTS WITH FEMUR HEAD BONE GRAFT), DUE GLENOID BASEPLATE MOBILIZATION AND THE LONGEST POLYAXIAL SCREW BREAKAGE. ALL DEVICES HAVE BEEN REVISED AND A CEMENT SPACER WAS IMPLANTED SUCCESSFULLY. NO INFECTION DETECTED TILL NOW, THE PATIENT SHOULDER WAS INFLAMED.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 15326887 ↗
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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