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	Unstable (1667)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since very little information is available, the manufacturer is currently trying to collect further information to better investigate the case.The manufacturer will submit a final mdr as soon as the investigation is complete.
Event or Problem Description
Shoulder revision surgery performed on (b)(6) 2025, due to instability.The following product was removed: smr finned humeral body (part code 1350.15.110, lot number unknown and sterilization unknown).According to the information available so far, there were also other components that were removed together with the smr finned humeral body but could not get the implant information or sizes for them.Date of revision surgery is unknown.The patient is female, date of birth (b)(6) 1952.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: 23944367
• Report Number: 3008021110-2026-00004
• Device Sequence Number: 21520235
• 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 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: 1350.15.110
• 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