MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; SMR SHOULDER - GLENOSPHERE DIA. 42 MM

Model Number	1374.09.131
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the manufacturing charts of the components removed, no pre-existing anomalies have been found in the items belonging to the same product code and lot number as the devices involved in the revision surgery hereby reported.The manufacturer will submit a final mdr as soon as the investigation is complete.
Event or Problem Description
Revision surgery due to instability performed on (b)(6) 2025.Patient underwent surgery for a reverse shoulder on (b)(6) 2025, in which the following components were implanted: - short stem plus #5 (part code 1357.14.236, lot number 2413552, sterilization (b)(4)) - prima reverse tray #short (part code 1367.15.010, lot number 2434587, sterilization (b)(4)) - prima rev.Insert #short d.42mm (part code 1367.54.300, lot number 2122627, sterilization (b)(4)) - smr glenosphere ø 42mm (part code 1374.09.131, lot number 2123235, sterilization (b)(4)) - smr small-r connector +4 (part code 1374.15.314, lot number 2101336, sterilization (b)(4)) - smr metal-back glenoid small r (part code 1375.21.005, lot number 2402374, sterilization (b)(4)) thumb test was done on humeral cut surface prior to implantation of prima stem.Due to the size of the patient, the surgeon determined the necessity of this implant to achieve desired medialization of the humerus and lateralization of the glenoid components.Therefore, during the revision hereby reported, the glenosphere and the lateralized connector were removed and replaced by the following components: - smr glenosphere ø 40mm (part code 1374.09.121, lot number 2400301, sterilization (b)(4)) - smr small-r connector +2 (part code 1374.15.312, lot number 2410294, sterilization (b)(4)) the patient is a male, date of birth (b)(6) 1963.The event happened in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: SMR SHOULDER - GLENOSPHERE DIA. 42 MM
• 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: 23511053
• Report Number: 3008021110-2025-00142
• Device Sequence Number: 9732738
• Product Code: PHX
• UDI-Device Identifier: 08033390204538
• UDI-Public: 08033390204538
• Combination Product (Y/N): N
• PMA/510(K) Number: K212800
• 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): 11/10/2025

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: 1374.09.131
• Device Lot Number: 2123235
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2025
• 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