TEMA Elbow 1590.15.020Recalls & reported problems
Limacorporate SPA · Axle Large · Class 2 · Implant
All models of TEMA Elbow (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390128872), received between May 9, 2025 and May 9, 2025 — classified as 1 injury.
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Oct 2, 2024Open, Classified
Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
Z-0744-2025 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 9, 2025No Apparent Adverse Event; No Apparent Adverse Event
ON MARCH (B)(6) 2025, THE SURGEON LINKED A PREVIOUSLY IMPLANTED PROMADE CUSTOM TOTAL ELBOW ARTHROPLASTY AND AXLE. NOTHING WAS REMOVED. THE AXLE USED DURING SURGERY IS AXLE #LARGE (PRODUCT CODE: 1590.15.020, LOT: 2435933 - STER. (B)(6)) PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2025, AND ANOTHER SURGERY (WITHOUT REMOVING ANY COMPONENTS) TOOK PLACE ON (B)(6) 2025 (REPORTED WITH MDR REPORT NUMBER: 3008021110-2025-00021). THE EVENT OCCURRED IN US.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21993925 ↗
Other Prosthesis, Elbow, Semi-Constrained, Cemented devices
- TEMA Elbow 1590.15.010Limacorporate SPA · Prosthesis, Elbow, Semi-Constrained, Cemented2 recalls3 reports
- 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
- CRF II - RADIAL PROSTHESIS DTJ022Tornier · 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 · each recall links to the FDA recall notice
- 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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