MAUDE Adverse Event Report: LIMACORPORATE S.P.A. TEMA ELBOW SYSTEM; ULNAR STEM U5

Model Number	1575.14.010
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Joint Laxity (4526)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of production records for complained component has been performed and did not highlight any anomaly nor non-conformity relevant to the issue.The manufacturer will submit a final report as soon as the investigation is completed.
Event or Problem Description
Upcoming elbow revision surgery due to loosening of ulnar stem discovered in early (b)(6) 2026.Complete medical history of the patient is below detailed.The original surgery was performed on (b)(6) 2023, and following tema components were implanted: - humeral stem #h6 (pn 1504.14.061); - humeral body small (pn 1550.15.111); - ulnar liner small (pn1560.50.011); - ulnar body small (pn 1552.14.011); - ulnar stem #u5.5 (pn 1575.14.020); - axle small (pn 1590.15.010).On (b)(6) 2023, pre-existing ulnar components were revised and replaced with following ones: - tema elbow ulnar stem #u5 (pn 1575.14.010, lot.2224203, ster.(b)(4)); - tema elbow ulnar body small (pn 1552.14.011, lot.2225795, ster.(b)(4)); - tema elbow ulnar liner small (pn 1560.50.011, lot.18at1ru, ster.(b)(4)); - tema elbow axle small (pn 1590.15.010, lot.2303175, ster.(b)(4)).As a result of the loosening of ulnar stem #u5, hereby reported, a custom implant ((b)(6)) has been requested.Date of revision surgery has not been defined yet.Patient is female, date of birth (b)(6) 1964.Event occurred in the united states.

• Brand Name: TEMA ELBOW SYSTEM
• Common Device Name: ULNAR STEM U5
• 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: 24813213
• Report Number: 3008021110-2026-00171
• Device Sequence Number: 12268882
• Product Code: JDC
• UDI-Device Identifier: 08033390128834
• UDI-Public: 8033390128834
• Combination Product (Y/N): N
• PMA/510(K) Number: K181362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 04/07/2026

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: 1575.14.010
• Device Lot Number: 2224203
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2026
• 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: Female