Glenoid Reconstruction System 04.01.0300Recalls & reported problems
Medacta International SA · GRS baseplate - Ø24.5x20 · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630345710291), received between Nov 21, 2024 and Nov 21, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Osseointegration Problem” (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
- Osseointegration Problem1
Patient problems
- Inadequate Osseointegration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2024Osseointegration Problem; Osseointegration Problem
SHOULDER REVISION SURGERY ON THE RIGHT SIDE PERFORMED ON THE (B)(6) 2024. LOOSENING OF THE GLENOID COMPONENTS (BONE OF INSUFFICIENT QUALITY FOR A GOOD HOLD OF THE GRS BASEPLATE DESPITE THE GRAB AND THE 4 SCREWS.) PRIMARY SURGERY PERFORMED ON THE (B)(6) 2021. 1ST REVISION SURGERY PERFORMED ON THE (B)(6) 2024 FOR INFECTION. EXPLANTATION OF ALL PRIMARY COMPONENTS. REIMPLANTATION OF NEW REVERSE SHOULDER COMPONENTS + BONE GRAFT AND WITH A LONG HUMERAL STEM. 2ND REVISION SURGERY PERFORMED ON THE (B)(6) 2024 FOR LUXATION OF GLENOSPHERE FROM BASEPLATE. EXPLANTATION OF THE LONG HUMERAL STEM WITH THE METAPHYSIS AND THE LINER, EXPLANTATION OF THE GLENOSPHERE (TO TEST THE STABILITY OF THE BASEPLATE AND THE GRAFT). REIMPLANTATION OF A NEW LONG HUMERAL STEM (CEMENTED) WITH A NEW METAPHYSIS AND LINER +6MM (155 DEGREES) AND IMPLANTATION OF A NEW GLENOSPHERE (LATERALIZED). 3RD REVISION SURGERY PERFORMED (B)(6) 2024 FOR GRS BASEPLATE LOOSENSING. EXPLANTATION OF ALL COMPONENTS EXCEPT THE LONG HUMERAL STEM. WAITING FOR A NEW PLANNING FOR A GLENOID CUSTOM IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 20746067 ↗
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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