TEMA Elbow 1552.14.011Recalls & reported problems
Limacorporate SPA · Ulnar Body small right · Class 2 · Implant
All models of TEMA Elbow (15)
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 08033390140058), received between Aug 2, 2025 and Aug 2, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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
- Patient Device Interaction Problem1
Patient problems
- Joint Laxity1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
ELBOW REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO ULNAR LOOSENING. PREVIOUS SURGERY PERFORMED ON (B)(6) 2024. THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED WITH NEW ONES: - ULNAR BODY SMALL RIGHT + SCREW (PART CODE 1552.14.011, LOT NUMBER 2308531, STERILIZATION (B)(4). - ULNAR STEM #U7 (PART CODE 1575.14.050, LOT NUMBER 1906323, STERILIZATION (B)(4)). - ULNAR LINER SMALL RIGHT (PART CODE 1560.50.011, LOT NUMBER 19AT1CQ, STERILIZATION (B)(4)). - AXLE #SMALL (PART CODE 1590.15.010, LOT NUMBER 2303175, STERILIZATION (B)(4)). PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1962. THE EVENT HAPPENED IN THE UNITED STATES.
Patient problems: Joint Laxity
MAUDE report 22694102 ↗
Other Prosthesis, Elbow, Semi-Constrained, Cemented devices
- TEMA Elbow 1590.15.010Limacorporate SPA · Prosthesis, Elbow, Semi-Constrained, Cemented2 recalls3 reports
- TEMA Elbow 1590.15.020Limacorporate SPA · Prosthesis, Elbow, Semi-Constrained, Cemented1 recall1 report
- Latitude™ - Elbow DKY068Tornier, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED20 reports
- DURALOC 1241-46-526Depuy Orthopaedics, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED17 reports
- Latitude™ - Elbow DKY067Tornier, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED8 reports
- RHS - RADIAL PROSTHESIS DTJ302Tornier · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED6 reports
- Latitude™ - Elbow DKY082Tornier, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED5 reports
- Latitude™ - Elbow DKY216Tornier, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED5 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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