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

Model Number	1590.15.020
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The check of manufacturing charts did not highlight any pre-existing anomalies on pieces with lot number 2435933.This is the first and only complaint received about the lot number involved.A final report will be submitted after the investigation is completed.
Event or Problem Description
On march (b)(6) 2025, the surgeon linked a previously implanted promade custom total elbow arthroplasty and axle.Nothing was removed.The axle used during surgery is axle #large (product code: 1590.15.020, lot: 2435933 - ster.(b)(6)) previous surgery was performed on (b)(6) 2025, and another surgery (without removing any components) took place on (b)(6) 2025 (reported with mdr report number: 3008021110-2025-00021).The event occurred in us.

• Brand Name: TEMA ELBOW
• Common Device Name: AXLE LARGE
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova; san daniele del friuli, udine 30038
• MDR Report Key: 21993925
• Report Number: 3008021110-2025-00051
• Device Sequence Number: 4263530
• Product Code: JDB
• UDI-Device Identifier: 08033390128872
• UDI-Public: 08033390128872
• 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): 05/09/2025

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: 1590.15.020
• Device Catalogue Number: 1590.15.020
• Device Lot Number: 2435933
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 05/09/2025
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown