Shoulder System 04.01.0182Recalls & reported problems
Medacta International SA · Short Humeral diaphysis - cementless - 9 · Class 2 · Implant
All models of Shoulder System (63)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630040715904), received between Jul 30, 2018 and Sep 3, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Fell” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Fell1
- Failure to Disconnect1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Aseptic loosening1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
AT APPROXIMATELY 5 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH PAIN DUE TO A LOOSE STEM, THE CAUSE OF WHICH IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND LINER WITH COMPONENTS FROM A COMPETITOR. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening
MAUDE report 22949799 ↗MalfunctionJul 30, 2018Failure to Disconnect; Device Fell
DURING SURGERY IT WAS NOTICED THAT THERE IS EXTREME DIFFICULTY DISENGAGING THE FINAL SHORT STEM IMPLANT FROM THE ASSEMBLY TOOL. THE SURGEON DROPPED THE HEAD AND STEM AS A RESULT OF THE DIFFICULTY USING THE INSTRUMENTS. THE SURGEON UPSIZED THE IMPLANTS. THERE WAS A DELAY OF APPROXIMATELY 10 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7731859 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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