Shoulder System 04.01.0213Recalls & reported problems
Medacta International SA · Long humeral diaphysis - L160 - 6 · Class 2 · Implant
All models of Shoulder System (63)
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 07630040733922), received between Jul 13, 2022 and Jul 13, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Component Missing” (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.
Most reported problems
Device problems
- Component Missing1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 13, 2022Component Missing; Loosening of Implant Not Related to Bone-Ingrowth
AT ABOUT 9 DAYS AFTER THE PRIMARY SURGERY (OF MEDACTA PRODUCTS), THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE HUMERAL DIAPHYSIS COMPONENT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE DIAPHYSIS, METAPHYSIS, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAS A PREVIOUS REVISION SURGERY OF COMPETITOR'S PRODUCTS: TORNIER REVERSE 6+ YEARS POST PRIMARY THAT WAS MISSING A LARGE PORTION OF THE PROXIMAL HUMERUS.
Patient problems: Pain
MAUDE report 15000061 ↗
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.
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