MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; FINNED HUMERAL BODIES WITH LOCKING SCREW

Model Number	1350.15.110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the manufacturing charts of the components involved in this event, no pre-existing anomaly was found out.The manufacturer will submit the final mdr as soon as the investigation is complete.
Event or Problem Description
Shoulder revision surgery was performed on (b)(6) 2025, due to rotator cuff failure.The patients cuff gave out and we had to convert from an anatomic to a reverse construct.The following components were removed: - smr finned humeral body (part code 1350.15.110, lot number 2221215, sterilization (b)(4)).- liner f.Met.Back glen.Standard (part code 1377.50.010, lot number 21at27c, sterilization unknown).Previous surgery took place on (b)(6) 2023.The patient is a female, date of birth (b)(6).The event happened in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: FINNED HUMERAL BODIES WITH LOCKING SCREW
• 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: 22609501
• Report Number: 3008021110-2025-00099
• Device Sequence Number: 9564269
• Product Code: HSD
• UDI-Device Identifier: 08033390002035
• UDI-Public: 08033390002035
• Combination Product (Y/N): N
• PMA/510(K) Number: K101263
• 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): 07/25/2025

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: 1350.15.110
• Device Lot Number: 2221215
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2025
• 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