Glenoid Reconstruction System 04.01.0302Recalls & reported problems
Medacta International SA · GRS baseplate - Ø24.5x20 +6mm · Class 2 · Implant
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 07630345710314), received between Jun 25, 2024 and Apr 14, 2026 — classified as 3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Osseointegration Problem2
- Migration1
Patient problems
- Aseptic loosening1
- Inadequate Osseointegration1
- Insufficient Information1
- Joint Dislocation1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 14, 2026Device Dislodged or Dislocated; Osseointegration Problem
AT ABOUT 1 YEAR AND 5 MONTHS AFTER THE PRIMARY, AN INTRA-PROSTHETIC DISLOCATION BETWEEN THE GLENOSPHERE AND THE GLENOID BASEPLATE OCCURRED, ALONG WITH LOOSENING OF THE GLENOID BASEPLATE. AGLENOSPHERE GUIDE WAS NOT USED DURING THE PRIMARY PROCEDURE.
Patient problems: Aseptic loosening; No Clinical Signs, Symptoms or Conditions
MAUDE report 24871727 ↗InjuryAug 22, 2024Migration; Migration
WHILE IN PHYSICAL THERAPY, IT WAS OBSERVED THAT THE BASEPLATE SHIFTED OUT POSTERIORLY OUTSIDE OF THE GLENOID BONE AND THE CAUSE IS UNKNOWN. AT 2 MONTHS FROM THE PRIMARY, THE SURGEON CONVERTED THE PATIENT FROM A REVERSE TO A HEMI. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Insufficient Information
MAUDE report 20038412 ↗InjuryJun 25, 2024Device Dislodged or Dislocated; Osseointegration Problem; Device Dislodged or Dislocated; Osseointegration Problem
PRIMARY SURGERY ON (B)(6) 2023 AFTER A TONIC CLONIC SEIZURE WITH POSTERIOR LUXATIONS ON BOTH THE LEFT AND RIGHT SHOULDER ON (B)(6) 2023. BONE GRAFTS USED. REVISION SURGERY PERFORMED ON (B)(6) 2024 AFTER RECURRENT SHOULDER LUXATIONS ON THE RIGHT SIDE AND GLENOID BASEPLATE LOOSENING. CHANGE OF BASEPLATE, SCREWS, GLENOSPHERE AND LINER.
Patient problems: Inadequate Osseointegration; Joint Dislocation
MAUDE report 19603233 ↗
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- 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
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- 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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