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

Model Number	1590.15.010
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
Checking the manufacturing charts of the involved lot n.2435932, no pre-existing anomaly was found on the 18 devices manufactured respectively.This is the first and only complaint received on this lot.We submit a final mdr when the investigation is complete.

• Brand Name: TEMA ELBOW
• Common Device Name: TEMA ELBOW - AXLE SMALL
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ,; IT 33038,
• MDR Report Key: 21993936
• Report Number: 3008021110-2025-00052
• Device Sequence Number: 4263537
• Product Code: JDB
• UDI-Device Identifier: 08033390128865
• UDI-Public: 08033390128865
• Combination Product (Y/N): N
• PMA/510(K) Number: K222807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/08/2025

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 Catalogue Number: 1590.15.010
• Device Lot Number: 2435932
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 05/09/2025
• 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