MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.14MM

Model Number	1304.15.140
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation checking the manufacturing charts of the devices involved, no pre-existing anomaly was found in the items belonging to the same product codes and lot number as the components removed.The manufacturer will submit a final mdr as soon as the investigation is complete.
Event or Problem Description
Revision surgery performed on (b)(6) 2025, due to poor bone quality.The stem needed to be upsized.The following components were removed: - smr cementless finned stem (part code 1304.15.140, lot number 2317201, sterilization (b)(4)).- reverse humeral body 140° (part code 1352.15.011, lot number 2414113, sterilization (b)(4)).- smr rev.Liner retentive +6 mm (part code 1361.50.820, lot number 20at1uk, sterilization (b)(4)).- smr glenosphere dia.36mm (part code 1374.09.111, lot number 2433397, sterilization (b)(4)).- smr small-r connector +2 (part code 1374.15.312, lot number 2432234, sterilization (b)(4)).The above-mentioned components were replaced by the following new ones: - smr small-r connector +4 (part code 1374.15.314, lot number 2433782, sterilization (b)(4)).- smr glenosphere dia.40mm (part code 1374.09.121, lot number 2432907, sterilization (b)(4)).- smr finned stem (part code 1304.15.170, lot number 2101797, sterilization 2100099).- reverse humeral body 140° (part code 1352.15.011, lot number 2422030, sterilization (b)(4)).- extension for reverse humeral body (part code 1352.15.001, lot number 2431805, sterilization (b)(4)).- smr rev.Liner retentive +3 mm (part code 1365.50.816, lot number 20at4v6, sterilization (b)(4)).Previous surgery was performed on (b)(6) 2025.The patient is a female, date of birth (b)(6) 1953.The event happened in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.14MM
• 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: 21966244
• Report Number: 3008021110-2025-00044
• Device Sequence Number: 18173482
• Product Code: HSD
• UDI-Device Identifier: 08033390000888
• UDI-Public: 08033390000888
• Combination Product (Y/N): N
• PMA/510(K) Number: K101263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 05/06/2025

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: 1304.15.140
• Device Lot Number: 2317201
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2025
• 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