MAUDE Adverse Event Report: LIMACORPORATE S.P.A TEMA ELBOW; HUMERAL STEM H6 LEFT

Model Number	1504.14.060
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Loose body in joint (4926)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2025 due to loosening.Patient was scheduled for a triceps repair and surgeon noticed that the humeral stem loosened.Revision was therefore performed replacing humeral stem (pn 1504.14.060) and body (pn 1550.15.110) only.Surgery was completed as intended.Previous surgery is unknown, as well as complete information of original implant.The event occurred in the united states.
Additional Manufacturer Narrative
Explanted components have been discarded therefore cannot be returned to manufacturer for identification and analysis.No review of manufacturing records for complained parts can be performed either since product information is unknown.No x-rays nor pictures of explanted components were provided either.From follow-up communication with complaint source it was confirmed that no further information regarding the case can be retrieved, therefore no further root cause investigation is possible.Taking into account the involved product family tema elbow, no adverse trend has been identified for reported issue in the last year.According to investigation carried out, no corrective action is needed for this event.If any additional information is received that would change or alter any conclusion, a supplemental report will be filed accordingly.The manufacturer will continue monitoring the market in order to detect any similar event.

• Brand Name: TEMA ELBOW
• Common Device Name: HUMERAL STEM H6 LEFT
• 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: 24176356
• Report Number: 3008031110-2026-00041
• Device Sequence Number: 9979778
• Product Code: JDC
• UDI-Device Identifier: 08033390128810
• UDI-Public: 8033390128810
• Combination Product (Y/N): N
• PMA/510(K) Number: K181362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/26/2026

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: 1504.14.060
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2026
• 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