MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER SYSTEM; GLENOSPHERE DIA. 40 MM

Model Number	1374.09.121
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the manufacturing charts of the components removed in the revision surgery hereby reported, 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 performed on (b)(6) 2025, due to dislocation, patient dislocated and needed to be lateralized.The following components were removed and replaced by new ones: - smr reverse liner retentive (part code 1365.50.821, lot number 24at0y0, sterilization 2400221) - smr glenosphere ø 40mm (part code 1374.09.121, lot number 2407737, sterilization 2400098) - smr small/std connector +2 (part code 1374.15.322, lot number 2205023, sterilization 2200081) previous surgery took place on (b)(6) 2025, registered as internal complaint(b)(4) (and reported as mfr.3008021110-2025-00107).The patient is a male, date of birth (b)(6) 1942.The event happened in the united states.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: GLENOSPHERE DIA. 40 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: 22620878
• Report Number: 3008021110-2025-00098
• Device Sequence Number: 21065986
• Product Code: MBF
• UDI-Device Identifier: 08033390123129
• UDI-Public: 8033390123129
• Combination Product (Y/N): N
• PMA/510(K) Number: K163397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2026

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: 1374.09.121
• Device Lot Number: 2407737
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 07/03/2026
• 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 Age: 82 YR
• Patient Sex: Male