Shoulder System 04.01.0185Recalls & reported problems
Medacta International SA · Short Humeral diaphysis - cementless - 12 · Class 2 · Implant
All models of Shoulder System (63)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630040715935), received between Sep 6, 2021 and Mar 3, 2026 — classified as 5 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 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 Appears to Trigger Rejection3
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Medical device site infection3
- Bone Fracture(s)1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMar 3, 2026Device Appears to Trigger Rejection
REVISION SURGERY DUE TO INFECTION, AT ABOUT 4 MONTHS POST PRIMARY THE SURGEON REVISED ALL THE DEVICES SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 24494915 ↗InjuryJan 23, 2026Device Appears to Trigger Rejection
REVISION SURGERY WAS PERFORMED APPROXIMATELY ONE YEAR AFTER THE PRIMARY PROCEDURE DUE TO A DEEP INFECTION. ALL IMPLANT COMPONENTS WERE REVISED BY THE SURGEON.
Patient problems: Medical device site infection
MAUDE report 24162754 ↗InjuryMay 13, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 3 YEARS 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA HARDWARE IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 22011829 ↗InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY FOR PERI-PROSTHETIC HUMERAL FRACTURE. THE SURGEON 4 DAYS AFTER PRIMARY SURGERY REVISED SUCCESSFULLY THE STEM, THE METAPHYSIS AND THE DIAPHYSIS.
Patient problems: Bone Fracture(s)
MAUDE report 16520980 ↗InjurySep 6, 2021Adverse Event Without Identified Device or Use Problem
2 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 12427665 ↗
Other Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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.
How reports and recalls are matched · Editorial policy · Report an error on this page