MAUDE Adverse Event Report: LIMACORPORATE S.P.A. TEMA ELBOW; ULNAR BODY SMALL RIGHT

Model Number	1552.14.011
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Elbow revision surgery performed on (b)(6) 2025, due to ulnar loosening.Previous surgery performed on (b)(6) 2024.The following components were removed and replaced with new ones: - ulnar body small right + screw (part code 1552.14.011, lot number 2308531, sterilization (b)(4).- ulnar stem #u7 (part code 1575.14.050, lot number 1906323, sterilization (b)(4)).- ulnar liner small right (part code 1560.50.011, lot number 19at1cq, sterilization (b)(4)).- axle #small (part code 1590.15.010, lot number 2303175, sterilization (b)(4)).Patient is a male, date of birth (b)(6) 1962.The event happened in the united states.
Additional Manufacturer Narrative
Checking the manufacturing charts, no pre-existing anomaly, that could have contributed to the event, have been discovered on the items belonging to the lot number 2308531/sterilization (b)(4), and lot number 1906323/sterilization (b)(4).The manufacturer will submit a final mdr as soon as the investigation is complete.

• Brand Name: TEMA ELBOW
• Common Device Name: ULNAR BODY SMALL RIGHT
• 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: 22694102
• Report Number: 3008021110-2025-00101
• Device Sequence Number: 12989720
• Product Code: JDB
• UDI-Device Identifier: 08033390140058
• UDI-Public: 08033390140058
• Combination Product (Y/N): N
• PMA/510(K) Number: K222807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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): 08/02/2025

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: 1552.14.011
• Device Lot Number: 2308531
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2025
• 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: Required Intervention
• Patient Sex: Unknown