TEMA Elbow 1575.14.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390128834), received between Aug 30, 2022 and Apr 8, 2026 — classified as 2 injuries.

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.

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.

• InjuryApr 8, 2026Patient Device Interaction Problem

  UPCOMING ELBOW REVISION SURGERY DUE TO LOOSENING OF ULNAR STEM DISCOVERED IN EARLY (B)(6) 2026. COMPLETE MEDICAL HISTORY OF THE PATIENT IS BELOW DETAILED. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2023, AND FOLLOWING TEMA COMPONENTS WERE IMPLANTED: - HUMERAL STEM #H6 (PN 1504.14.061); - HUMERAL BODY SMALL (PN 1550.15.111); - ULNAR LINER SMALL (PN1560.50.011); - ULNAR BODY SMALL (PN 1552.14.011); - ULNAR STEM #U5.5 (PN 1575.14.020); - AXLE SMALL (PN 1590.15.010). ON (B)(6) 2023, PRE-EXISTING ULNAR COMPONENTS WERE REVISED AND REPLACED WITH FOLLOWING ONES: - TEMA ELBOW ULNAR STEM #U5 (PN 1575.14.010, LOT. 2224203, STER. (B)(4)); - TEMA ELBOW ULNAR BODY SMALL (PN 1552.14.011, LOT. 2225795, STER. (B)(4)); - TEMA ELBOW ULNAR LINER SMALL (PN 1560.50.011, LOT. 18AT1RU, STER. (B)(4)); - TEMA ELBOW AXLE SMALL (PN 1590.15.010, LOT. 2303175, STER. (B)(4)). AS A RESULT OF THE LOOSENING OF ULNAR STEM #U5, HEREBY REPORTED, A CUSTOM IMPLANT ((B)(6)) HAS BEEN REQUESTED. DATE OF REVISION SURGERY HAS NOT BEEN DEFINED YET. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1964. EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 24813213 ↗
• InjuryAug 30, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ELBOW REVISION SURGERY PERFORMED ON (B)(6) 2021. DURING THIS REVISION ULNAR LINER SMALL, ULNAR BODY SMALL AND ULNAR STEM #5 PREVIOUSLY IMPLANTED ON (B)(6) 2020 HAVE BEEN REPLACED BY IMPLANTING A NEW ULNAR LINER (SAME SIZE), A NEW ULNAR BODY (SAME SIZE) AND A ULNAR STEM #7. CAUSE FOR REVISION IS UNKNOWN. EVENT HAPPENED IN US.

  Patient problems: Insufficient Information

  MAUDE report 15319826 ↗