MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SYSTEM; SMR SYSTEM - FINNED STEM DIA. 19 MM L. 80 MM

Model Number	1304.15.190
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	09/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
By checking the sterilization chart of the involved lot number, no pre-existing anomalies were highlighted.Therefore, we may state the manufactured pieces were released on the market conform.This is the first and only complaint received on lot: 2400630 - ster.(b)(4).
Event or Problem Description
The complaint source reported a revision surgery performed on (b)(6) 2025, due to low grad infection.The humeral stem (product code:1304.15.190 - lot: 2400630 - ster.(b)(4) was explanted.Previous surgery performed on (b)(6) 2024.Event occurred in germany.
Additional Manufacturer Narrative
By checking the sterilization chart of the involved lot number, no pre-existing anomalies were highlighted.Therefore, we can state that the device was regularly sterilized before being placed on the market.This is the first and only complaint received on lot n.2400630 and on sterilization n.(b)(4).The following additional details were requested to the complaint source, but never provided: product codes and lot numbers of other devices explanted during the revision surgery x-rays (pre-operative/post-operative) of the first surgery x-rays (pre-operative/post-operative) of the revision surgery bacteriological and/or histological results additional clinical data of the patient: approximate weight, approximate height, relevant clinical information, history of substance abuse, activity level.) with the few available information, a thorough complaint analysis is not possible and a definitive conclusion on the cause of the reported infection cannot be determined, however, based on the absence of pre-existing anomalies detected by the check of the sterilization charts, we classify this event as not product related.Pms data: based on company's pms data, the revision rate of smr cementless stems (family codes 130415110 to 130415240) due to infection is about 0.04% no corrective action was implemented following this complaint.The company will continue to monitor the market to promptly detect any further similar events.
Event or Problem Description
The complaint source reported a revision surgery performed on (b)(6) 2025, due to low grad infection.The humeral stem (product code:1304.15.190 - lot: 2400630 - ster.(b)(4) was explanted.The previous surgery was performed on (b)(6) 2024.Patient is male, 85 years old.This event occurred in germany.

• Brand Name: SMR SYSTEM
• Common Device Name: SMR SYSTEM - FINNED STEM DIA. 19 MM L. 80 MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale, 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 23130495
• Report Number: 3008021110-2025-00128
• Device Sequence Number: 9298194
• Product Code: HSD
• UDI-Device Identifier: 08033390270823
• UDI-Public: 08033390270823
• Combination Product (Y/N): N
• PMA/510(K) Number: K101263
• 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,Followup
• Report Date (Section B): 01/29/2026

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: 1304.15.190
• Device Catalogue Number: 1304.15.190
• Device Lot Number: 2400630
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 01/30/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown