TEMA Elbow 1504.14.100Recalls & reported problems
Limacorporate SPA · Humeral Stem H10 left · 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 08033390128827), received between Jul 13, 2026 and Jul 13, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 13, 2026Insufficient Device Problem Information
REVISION SURGERY OF ELBOW PROSTHESIS WAS PERFORMED ON (B)(6) 2024 FOR UNKNOWN REASON. 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), - ULNAR BODY LARGE LEFT + SCREW (PN 1552.15.020), - ULNAR LINER LARGE LEFT (PN 1560.50.020). 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), - HUMERAL BODY LARGE LEFT (PN 1550.15.020)., NO INDICATION REGARDING THE CEMENTATION ADOPTED WAS PROVIDED. ONE MONTH LATER, ON (B)(6) 2021, PATIENT WAS REVISED FOR THE THIRD TIME (MFR. 3008021110-2026-00287) FOR LOOSENING OF THE RECENTLY IMPLANTED HUMERAL STEM #H9 WITH A BIGGER STEM (HUMERAL STEM #H10 LEFT, PN 1504.1
Patient problems: Insufficient Information
MAUDE report 25797033 ↗
Other Prosthesis, Elbow, Constrained, Cemented devices
- DJO SURGICAL 540-00-000Encore Medical, L.P. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED64 reports
- Arcos Modular Revision Hip System 11-301321Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall7 reports
- DJO SURGICAL 540-01-001Encore Medical, L.P. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED55 reports
- Arcos Modular Revision Hip System 11-301302Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall5 reports
- Arcos Modular Revision Hip System 11-301343Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall1 report
- Bearing and Axle Bushing Assembly - Standard Elbow C-M113-1-301Howmedica Osteonics Corp. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 reports
- Comprehensive® SRS / Discovery® 211251Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 reports
- Comprehensive® SRS / Discovery® 211253Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 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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