TEMA Elbow 1550.15.120Recalls & reported problems
Limacorporate SPA · Humeral Body large 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 08033390175449), received between Jan 24, 2025 and Jan 24, 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
- Osteolysis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
ELBOW REVISION SURGERY PERFORMED ON (B)(6) 2024. PATIENT'S HUMERUS HAD AN OSTEOLYSIS REACTION AFTER HER LAST ELBOW SURGERY. THE FOLLOWING COMPONENTS WERE REMOVED: HUMERAL BODY LARGE LEFT+SCREW (PART CODE 1550.15.120, LOT NUMBER 2100718, (B)(4) ). AXLE #LARGE (PART CODE 1590.15.020, LOT NUMBER 2227696, (B)(4) ). CMD 23-1240 HUMERAL IMPLANT (PART CODE 9618.15.09Y, LOT NUMBER 2318226, (B)(4) ). THE HUMERAL STEM WAS FOUND LOOSE DURING THE TRICEPS REVISION SURGERY. THE SURGEON SAW SIMILAR REACTIONS IN TWO OTHER PATIENTS, BUT THE CAUSES HAVE NOT BEEN IDENTIFIED AS OF YET. THE PATIENT'S CLINICAL HISTORY IS THE FOLLOWING: THE PATIENT UNDERWENT THE SURGERY TO IMPLANT THE CUSTOM-MADE DEVICE #23-1031 ON (B)(6) 2023 (PLEASE REFER TO POSTOPERATIVE FOLLOW-UP REPORT FOR FDA COMPASSIONATE USE REQUEST U230471). THE HUMERAL COMPONENT OF CUSTOM-MADE DEVICE #23-1031 WAS REMOVED ON (B)(6) 2023, DUE TO LOOSENING AFTER PHYSICAL THERAPY. THIS REVISION WAS REGISTERED WITH THE CUSTOMER COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR. 3008021110-2023-00082. THE CUSTOM-MADE DEVICE #23-1240 WAS IMPLANTED (B)(6) 2023. THE CUSTOM-MADE DEVICE #23-1240 WAS REMOVED ON (B)(6) 2024, DUE TO OSTEOLYSIS (EVENT HEREBY
Patient problems: Osteolysis
MAUDE report 21228817 ↗
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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