TEMA Elbow 1552.14.021Recalls & reported problems
Limacorporate SPA · Ulnar Body large right · 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 08033390140089), received between Nov 18, 2022 and Nov 18, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Joint Laxity1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 18, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
ELBOW REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO INSTABILITY AND LOOSENING. PATIENT PRESENTED WITH INCREASED INSTABILITY. DURING THE REVISION SURGERY THE FOLLOWING COMPONENTS WERE EXPLANTED: HUMERAL SAFETY SCREW HUM.BODY (PRODUCT CODE 1550.15.900, LOT NUMBER 1814381, STERILIZATION NUMBER 1900179). ULNAR BODY LARGE RIGHT + SCREW (PRODUCT CODE 1552.14.021, LOT NUMBER 1811310, STERILIZATION NUMBER 1900181). ULNAR LINER - LARGE RIGHT (PRODUCT CODE 1560.50.021, LOT NUMBER 18AT1RV, STERILIZATION NUMBER 1900225). ULNAR STEM #U5 (PRODUCT CODE 1575.14.010, LOT NUMBER 2001330, STERILIZATION NUMBER 2000092). THE ULNAR COMPONENT WAS DISLODGED FROM THE ULNA. HUMERAL COMPONENT WAS NOT EXPLANTED AND THERE ARE NO SIGNS OF INFECTION. SURGERY WAS COMPLETED AND ULNAR IMPLANT WAS REMOVED. SEVERAL CULTURES WERE TAKEN DURING THE SURGERY BUT THERE IS NO MENTION OF INFECTION. PATIENT'S CLINICAL HISTORY: EXTENSIVE SURGICAL HISTORY ON THE RIGHT ELBOW. HE HAD A METASTATIC LESION TO THE RIGHT HUMERUS (RENAL CELL CARCINOMA) WITH PATHOLOGIC FRACTURE THAT WENT ON TO NON-UNION AND SUBSEQUENTLY WAS TREATED WITH A FREE FIBULA VASCULARIZED GRAFT, FOLLOWED BY EXTERNAL FIXATOR, AND DEBRIDEMENT PROCEDURES FOR RE
Patient problems: Joint Laxity
MAUDE report 15823725 ↗
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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