Shoulder System 04.01.0154Recalls & reported problems
Medacta International SA · Glenoid baseplate Ø27x15 · Class 2 · Implant
All models of Shoulder System (63)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630040706414), received between Apr 10, 2018 and Mar 3, 2026 — classified as 6 injuries, 1 malfunction.
The most frequently reported specific device problem is “Contamination” (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 Problem2
- Contamination1
- Device Appears to Trigger Rejection1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Loss of Osseointegration1
- Malposition of Device1
- Mechanical Problem1
Patient problems
- Unspecified Infection3
- Insufficient Information2
- Implant Pain1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2026Mechanical Problem
THE GLENOSPHERE SCREW COULD NOT BE FULLY INSERTED IN THE BASEPLATE. RESIDUAL BONE AROUND THE BASEPLATE WAS SUSPECTED, AND THE SURROUNDING AREA WAS CLEARED AGAIN, BUT THE SAME ISSUE OCCURRED. WHEN THE SCREW WAS INSERTED WITHOUT THE GLENOSPHERE AS A TEST, THE SCREW AGAIN STOPPED MIDWAY. THE SCREW WAS LEFT AT THE POINT WHERE IT STOPPED. THE SURGERY WAS COMPLETED IMPLANTING THE GLENOSPHERE WITH THE GLENOSPHERE SCREW NOT COMPLETELY SCREWED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24494903 ↗InjuryJul 3, 2025Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
AT 3 YEARS 11 MONTHS, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE BASEPLATE, AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE BASEPLATE, GLENOSPHERE, LINER, AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 22395931 ↗InjurySep 1, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 4 MONTHS FROM THE PRIMARY, REVISION SURGERY DUE TO INFECTION. THE SURGEON REVISED ALL THE IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 17669144 ↗InjuryJul 7, 2022Malposition of Device; Malposition of Device
AT ABOUT 5 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE BASEPLATE POSITION WAS MALALIGNED INFERIORLY. ACCORDING TO THE REVISION SURGEON, THE IMPLANT WAS MALPOSITIONED DURING THE PRIMARY SURGERY. THE SURGEON DECIDED TO REVISE THE METAPHYSIS, AND USED COMPETITOR'S BASEPLATE AND GLENOSPHERE TO REVISE INCLINATION/ANGLE OF THE IMPLANT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Insufficient Information
MAUDE report 14942677 ↗InjuryMar 12, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY 4 MONTHS AFTER PRIMARY FOR BASE PLATE LOOSENING. THE SURGEON REVISED SUCCESSFULLY THE PATIENT SHOULDER REPLACING THE GLENOIDS IMPLANTS AND THE HUMERAL REVERSE HC LINER. THE GLENOSPHERE WAS FOUND COUPLED TO THE BASEPLATE DURING THE REVISION.
Patient problems: Insufficient Information
MAUDE report 11473640 ↗InjuryNov 20, 2019Adverse Event Without Identified Device or Use Problem
REVISION SURGERY PERFORMED 1 MONTH AFTER THE PRIMARY DUE TO AN INFECTION. THE PATHOGEN IS CUTIBACTERIUM ACNES ET STAPHYLOCOQUE EPIDERMIDIS. ALL IMPLANTS WERE REVISED.
Patient problems: Unspecified Infection
MAUDE report 9346680 ↗InjuryApr 10, 2018Contamination
ABOUT 8 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT SHOULDER FOR AN INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 7412279 ↗
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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