TEMA Elbow 1590.15.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033390128865), received between May 24, 2023 and Dec 12, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (2 reports).

2 FDA recall records name this device's identifier, 2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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 · FDA record ↗

2. Jan 25, 2023Open, Classified

   Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.

   Z-1261-2023 · Root cause: Employee error · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2025Unstable; Unstable

  CONVERSION SURGERY PERFORMED ON (B)(6) 2025 DUE TO ELBOW INSTABILITY. THE PRE-EXISTING IMPLANT WAS NOT REMOVED AS THERE WERE NO SIGNS OF BREAKAGE, BUT SURGEON IMPLANTED THE AXLE #SMALL (PART NUMBER: 1590.15.010, LOT: 2504642, STERILIZATION: 2500077) BETWEEN THE HUMERAL AND ULNAR COMPONENTS TO LINK THEM TO IMPROVE STABILITY. THE SURGERY WAS COMPLETED AS INTENDED. PREVIOUS SURGERY DATE AND LIST OF IMPLANTED COMPONENTS IS UNKNOWN. PATIENT IS A FEMALE, DATE OF BIRTH ON (B)(6) 1950. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 23789533 ↗
• InjuryMay 9, 2025No Apparent Adverse Event; No Apparent Adverse Event

  A CONVERSION SURGERY TOOK PLACE ON (B)(6) 2025, TO LINK AN AXLE TO A CUSTOM PROMADE COMPONENT IN A TOTAL ELBOW ARTHROPLASTY. THE SURGEON DID NOT REMOVE THE SUSPECTED COMPONENT, AS THERE WERE NO SIGNS OF BREAKAGE OR FRAGMENTATION. THE SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS INSPECTED PRIOR TO USE AND FOUND TO BE ACCEPTABLE. THE PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2025. PRODUCT IMPLANTED: AXLE #SMALL (PRODUCT CODE: 9159015010U03, LOT N.: 2435932, STERILIZATION N.: (B)(4)). PATIENT FEMALE, 78 YEARS OLD. EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993936 ↗
• InjuryMay 24, 2023Unstable; Use of Device Problem; Unstable; Use of Device Problem

  ELBOW REVISION SURGERY WAS PERFORMED ON (B)(6) 2020, TO IMPLANT AN AXLE - SMALL DEVICE, COMMERCIAL CODE: 1590.15.010 - LOT #: 1813818 - STER. #: (B)(6) TO STABILIZE LOOSE IMPLANTS. INITIAL SURGERY INVOLVED IMPLANTATION OF THE LISTED COMPONENTS BELOW. THE IFU STATES THAT THE COMPONENTS USED IN THE TEMA ELBOW SYSTEM ARE INTENDED FOR CEMENTED APPLICATIONS. THE SURGEON ELECTED TO USE AN OFF-LABEL USE USING AN UNCEMENTED APPLICATION. IMPLANTED COMPONENTS FROM INITIAL SURGERY: HUMERAL BODY - SMALL, COMMERCIAL CODE: 1550.15.011 - LOT #: 1814787 - STER. #: (B)(6); ULNAR LINER - SMALL, COMMERCIAL CODE: 1560.50.011 - LOT #: 18AT1RU - STER. #: (B)(6); HUMERAL STEM #H8, COMMERCIAL CODE: 1504.14.081 - LOT #: 1815323 - STER. #: (B)(6); ULNAR BODY-SMALL, COMMERCIAL CODE: 1552.14.011 - LOT #: 1814146 - STER. #: (B)(6); ULNAR STEM #U7, COMMERCIAL CODE: 1575.14.050 - LOT #: 1811263 - STER. #: (B)(6). INITIAL SURGERY: (B)(6) 2020. PATIENT: MALE. BIRTH DATE: (B)(6) 1945. APPROX. WEIGHT (INITIAL SURGERY): 79KG. ACTIVITY LEVEL: SEDENTARY. ADDITIONAL: POOR BONE QUALITY AND UNLINKED DURING INITIAL SURGERY. EVENT HAPPENED IN US.

  Patient problems: Joint Laxity

  MAUDE report 16990239 ↗