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

Model Number	1374.09.121
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explanted components have been discarded therefore are not available for return, identification and investigation.Lot number is unknown thus no review of manufacturing records for involved components can be performed.The manufacturer will provide a final report as soon as the investigation is completed.
Event or Problem Description
Revision surgery was performed on (b)(6) 2026 due to failure of glenoid components.Previous surgery is unknown, as well as complete product information of original implant.During revision the glenosphere (part number: 1374.09.121) has been replaced with a new one and lateralized with a small/std connector lateralized +2mm, and the reverse liner (part number: 1365.50.815) has been replaced.Surgery was completed as intended.The patient is male, date of birth on (b)(6) 1948.The event occurred in the united states.

• Brand Name: SMR SHOULDER
• 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: 24442717
• Report Number: 3008021110-2026-00123
• Device Sequence Number: 13353141
• Product Code: PHX
• 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 Explanted Year: 2026
• 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): 02/25/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2026
• 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: 77 YR
• Patient Sex: Female