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

Model Number	1360.50.810
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of production records of the explanted smr reverse liner has been performed and did not highlight any anomaly or non-conformity that could have contributed to the issue.The manufacturer will submit a final report as soon as the investigation is completed.
Event or Problem Description
Revision surgery has been performed on (b)(6) 2026 due to shoulder prosthesis instability.Previous surgery occurred on (b)(6) 2025.During the revision, pre-existing smr reverse liner standard (pn 1360.50.810, lot.24at5p6) has been removed and replaced with smr retentive liner +6mm (pn 1361.50.820).Also, the originally implanted glenosphere, from another manufacturer, has been removed and replaced with a new one.Surgery has been completed as intended.Patient is female, date of birth (b)(6) 1949.Event occurred in the united states.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: REVERSE LINERS 36MM (UHMWPE) STANDARD
• 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: 24813220
• Report Number: 3008021110-2026-00170
• Device Sequence Number: 21231002
• Product Code: PHX
• UDI-Device Identifier: 08033390273589
• UDI-Public: 8033390273589
• Combination Product (Y/N): N
• PMA/510(K) Number: K110598
• 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
• Report Date (Section B): 04/07/2026

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: 1360.50.810
• Device Lot Number: 24AT5P6
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2026
• 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: 76 YR
• Patient Sex: Female