MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; HUMERAL HEAD (COCRMO) - DIA.46MM H.15

Model Number	1321.09.461
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the manufacturing charts of the involved lot numbers, no pre-existing anomaly was discovered in the (b)(4) items belonging to the lot number: 2200831 and sterilization: 2200070, nor in the (b)(4) items belonging to the lot number: 2110034 and sterilization: 2100199.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 bone fracture.The patient fractured the glenoid in a previous surgery and had a hemi in.Converted the hemi to a reverse, removing the following components: smr humeral head d.46 h.15mm (part code: 1321.09.461, lot number: 2110034, sterilization: 2100199) prima 2mm eccentrical adaptor (part code: 1367.15.702, lot number: 2200831, sterilization: 2200070) previous surgery took place on (b)(6) 2023.The patient is a female, date of birth on (b)(6) 1948.The event happened in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: HUMERAL HEAD (COCRMO) - DIA.46MM H.15
• 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: 22923602
• Report Number: 3008021110-2025-00114
• Device Sequence Number: 18450561
• Product Code: KWT
• UDI-Device Identifier: 08033390116275
• UDI-Public: 08033390116275
• Combination Product (Y/N): N
• PMA/510(K) Number: K161476
• 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): 08/29/2025

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: 1321.09.461
• Device Lot Number: 2110034
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2025
• 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