TEMA Elbow 1504.14.090Recalls & reported problems
Limacorporate SPA · Humeral Stem H9 left · 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 08033390140249), received between Jul 13, 2026 and Jul 13, 2026 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem1
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.
InjuryJul 13, 2026Patient Device Interaction Problem
REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO LOOSENING OF HUMERAL COMPONENTS OF ELBOW PROSTHESIS. COMPLETE PATIENT CLINICAL HISTORY IS SUMMARIZED BELOW. PATIENT UNDERWENT PRIMARY SURGERY IN 2006 FOR FRACTURE WHEN AN ELBOW PROSTHESIS FROM ANOTHER MANUFACTURER WAS IMPLANTED. FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 WITH A COMPLETE CEMENTLESS TEMA ASSEMBLY CONSISTING OF: HUMERAL STEM #H7 LEFT (PN 1504.14.070) HUMERAL BODY LARGE LEFT + SCREW (PN 1550.15.020) ULNAR STEM #U6 (PN 1575.14.030 LOT 1816847 STER (B)(4) ULNAR BODY LARGE LEFT + SCREW (PN 1552.15.020 LOT 1714267 STER (B)(4) ULNAR LINER LARGE LEFT (PN 1560.50.020 LOT 16AT1WL STER (B)(4). PATIENT BONE QUALITY WAS REPORTED TO BE POOR. AFTER FEW MONTHS, SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 FOR HUMERAL STEM LOOSENING (MFR. 3008021110-2026-00286) AND THE ABOVE-MENTIONED HUMERAL COMPONENTS WERE REMOVED AND REPLACED WITH: HUMERAL STEM #H9 LEFT (PN 1504.14.090 LOT 1816474 STER (B)(4) HUMERAL BODY LARGE LEFT (PN 1550.15.020 LOT 1714541 STER (B)(4). NO INDICATION REGARDING THE CEMENTATION ADOPTED WAS PROVIDED. ONE MONTH LATER, ON (B)(6) 2021, PATIENT WAS REVISED FOR THE THIRD TIME (HEREBY REPORTED) FOR LO
Patient problems: Loose body in joint
MAUDE report 25797021 ↗
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.