MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER SYSTEM; REVERSE RETENTIVE LINER 40MM +6MM

Model Number	1365.50.821
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explanted components have not been returned to manufacturer therefore are not available for analysis.Review of production records has not been performed as complete information on components explanted during the revision surgery are unknown.The manufacturer will submit a final report as soon as the investigation is completed.
Event or Problem Description
Revision surgery was performed on (b)(6) 2026, due to wear of smr reverse liner retentive.Previous surgery is unknown as well as complete information of original implant.During the revision the pre-exiisting smr components were removed an replaced with: smr finned stem (pn1304.15.190); smr humeral body reverse (pn 1352.15.010); extension for humeral reverse body (pn 1352.15.001); smr reverse liner retentive (pn 1365.50.821); smr connector + screw (pn 1374.15.310); smr glenosphere eccentrical (pn 1376.09.041).Surgery has been completed as intended.Patient is male, date of birth (b)(6) 1965.Event occurred in the united states.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: REVERSE RETENTIVE LINER 40MM +6MM
• 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: 24813214
• Report Number: 3008021110-2026-00172
• Device Sequence Number: 6027621
• Product Code: PHX
• UDI-Device Identifier: 08033390102971
• UDI-Public: 8033390102971
• Combination Product (Y/N): N
• PMA/510(K) Number: K142139
• 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): 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: 1365.50.821
• 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: 61 YR
• Patient Sex: Male