MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER; REVERSE LINERS 36MM (UHMWPE) +3MM

Model Number	1360.50.815
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Checking the manufacturing charts, no pre-existing anomaly was discovered in the (b)(4) items belonging to the lot number 22at1yh, sterilization (b)(4).The manufacturer will submit a final mdr as soon as the investigation is complete.
Event or Problem Description
Revision surgery performed on (b)(6) 2025, due to glenoid loosening.It was implanted a third-party glenoid component.The following component was removed and replaced with a new smr retentive liner: - smr reverse liner + 3 mm (part code 1360.50.815, lot number 22at1yh, sterilization (b)(4)).Previous surgery took place on (b)(6) 2024.The patient is a female, date of birth (b)(6) 1952.The event happened in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: REVERSE LINERS 36MM (UHMWPE) +3MM
• 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: 22923288
• Report Number: 3008021110-2025-00111
• Device Sequence Number: 9162070
• Product Code: PHX
• UDI-Device Identifier: 08033390080620
• UDI-Public: 08033390080620
• Combination Product (Y/N): N
• PMA/510(K) Number: K110598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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: 1360.50.815
• Device Lot Number: 22AT1YH
• 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