MAUDE Adverse Event Report: LIMACORPORATE S.P.A TEMA ELBOW; HUMERAL STEM H10 RIGHT

Model Number	1504.14.101
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Loose body in joint (4926)
Date of Event	10/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of manufacturing and sterilization records did not identify any pre-existing anomaly or non-conformity on involved batch that could have contributed to reported issue.Through follow-up communication, it was learned that the revision surgery has not been planned yet.The patient went to the or for an irrigation and debridement due to a draining sinus and the loosening of humeral stem was discovered intra-operatively.According to medical history shared by medical personnel involved in the case, the patient has a history of diabetes and hypertension well-managed with appropriate therapies, and smokes one pack of cigarettes per day.Patient is a businessman, and he enjoys playing steel drums.The manufacturer will provide a final report as soon as the investigation is completed.
Event or Problem Description
Revision surgery performed on (b)(6) 2025 to explant a loose humeral stem.Original surgery was performed on (b)(6) 2023 implanting the following components: - tema humeral stem #h10 right (part number 15040.14.101, lot 1816476, sterilization (b)(6)), - tema humeral body - large right (part number 1550.15.121, lot 2019808, sterilization (b)(6)), - tema ulnar stem #u7 (part number 1575.14.050, lot 1906323, sterilization (b)(6)), - tema ulnar body large right (part number 1552.14.021, lot 2225798, sterilization (b)(6)), - tema ulnar liner large right (part number 1560.50.021, lot 2018at1rv, sterilization (b)(6)), - tema axle large (part number 1590.15.020, lot 2227696, sterilization (b)(6)).Ulnar components were revised on (b)(6) 2023, replacing the pre-existing stem with tema ulnar stem #u6 (part number 1575.14.030, lot 2100543, sterilization (b)(6)) and ulnar body, liner and axle with new ones of the same size.During the last surgery on (b)(6) 2025, the loose humeral stem has been removed and custom-made device has been requested due to bone loss at the humeral metaphysis.Reference (b)(4) has been assigned to the custom-made device request.Patient is male, date of birth unknown.The event occurred in the united states.

• Brand Name: TEMA ELBOW
• Common Device Name: HUMERAL STEM H10 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: 23943011
• Report Number: 3008021110-2025-00165
• Device Sequence Number: 7868993
• Product Code: JDC
• UDI-Device Identifier: 08033390140263
• UDI-Public: 8033390140263
• Combination Product (Y/N): N
• PMA/510(K) Number: K181362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 01/02/2026

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: 1504.14.101
• Device Lot Number: 1816476
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/02/2026
• 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: Unknown