TEMA Elbow 1504.14.101Recalls & reported problems
Limacorporate SPA · Humeral Stem H10 right · Class 2 · Implant
- 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 08033390140263), received between Jan 2, 2026 and Jan 2, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Loose body in joint1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 2, 2026Detachment of Device or Device Component
REVISION SURGERY PERFORMED ON (B)(6) 2025 TO EXPLANT A LOOSE HUMERAL STEM. ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2023 IMPLANTING THE FOLLOWING COMPONENTS: - TEMA HUMERAL STEM #H10 RIGHT (PART NUMBER 15040.14.101, LOT 1816476, STERILIZATION (B)(6)), - TEMA HUMERAL BODY - LARGE RIGHT (PART NUMBER 1550.15.121, LOT 2019808, STERILIZATION (B)(6)), - TEMA ULNAR STEM #U7 (PART NUMBER 1575.14.050, LOT 1906323, STERILIZATION (B)(6)), - TEMA ULNAR BODY LARGE RIGHT (PART NUMBER 1552.14.021, LOT 2225798, STERILIZATION (B)(6)), - TEMA ULNAR LINER LARGE RIGHT (PART NUMBER 1560.50.021, LOT 2018AT1RV, STERILIZATION (B)(6)), - TEMA AXLE LARGE (PART NUMBER 1590.15.020, LOT 2227696, STERILIZATION (B)(6)). ULNAR COMPONENTS WERE REVISED ON (B)(6) 2023, REPLACING THE PRE-EXISTING STEM WITH TEMA ULNAR STEM #U6 (PART NUMBER 1575.14.030, LOT 2100543, STERILIZATION (B)(6)) AND ULNAR BODY, LINER AND AXLE WITH NEW ONES OF THE SAME SIZE. DURING THE LAST SURGERY ON (B)(6) 2025, THE LOOSE HUMERAL STEM HAS BEEN REMOVED AND CUSTOM-MADE DEVICE HAS BEEN REQUESTED DUE TO BONE LOSS AT THE HUMERAL METAPHYSIS. REFERENCE (B)(4) HAS BEEN ASSIGNED TO THE CUSTOM-MADE DEVICE REQUEST. PATIENT IS MALE, DATE OF BIRTH UNKNOWN
Patient problems: Loose body in joint
MAUDE report 23943011 ↗
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™ EV 0030221Tornier, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED5 reports
- Latitude™ - Elbow DKY082Tornier, Inc. · PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.