MAUDE Adverse Event Report: LIMACORPORATE S.P.A TEMA ELBOW; AXLE SMALL

Model Number	1590.15.010
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of manufacturing records of implanted axle highlighted no pre-existing anomaly on involved batch, confirming that the device has been released according to specification.The manufacturer will provide a final report as soon as the investigation is completed.
Event or Problem Description
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.

• Brand Name: TEMA ELBOW
• Common Device Name: AXLE SMALL
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 23789533
• Report Number: 3008021110-2025-00169
• Device Sequence Number: 5546859
• Product Code: JDB
• UDI-Device Identifier: 08033390128865
• UDI-Public: 8033390128865
• Combination Product (Y/N): N
• PMA/510(K) Number: K222807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1590.15.010
• Device Lot Number: 2504642
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown