TEMA Elbow 1504.14.060Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390128810), received between Jan 26, 2026 and Jul 13, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  CUSTOM MADE DEVICE WAS REQUESTED FOR A PATIENT WITH SEPTIC LOOSENING OF HUMERAL COMPONENT OF TEMA ELBOW PROSTHESIS DUE TO RHEAUMATOID BONE LOSS. REVISION SURGERY HAS NOT BEEN PERFORMED YET. 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 LOOSENIN

  Patient problems: Joint Laxity; Medical device site infection

  MAUDE report 25797024 ↗
• InjuryJan 26, 2026Patient Device Interaction Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO LOOSENING. PATIENT WAS SCHEDULED FOR A TRICEPS REPAIR AND SURGEON NOTICED THAT THE HUMERAL STEM LOOSENED. REVISION WAS THEREFORE PERFORMED REPLACING HUMERAL STEM (PN 1504.14.060) AND BODY (PN 1550.15.110) ONLY. SURGERY WAS COMPLETED AS INTENDED. PREVIOUS SURGERY IS UNKNOWN, AS WELL AS COMPLETE INFORMATION OF ORIGINAL IMPLANT. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Loose body in joint

  MAUDE report 24176356 ↗