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

Model Number	1365.50.820
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Shoulder revision surgery has been performed on (b)(6), 2026, due to failure of glenoid components.Previous surgery occurred on (b)(6), 2024, when a reverse configuration consisting of both limacorporate and another manufacturer components were implanted.During the revision surgery hereby reported, the pre-existing reverse shoulder configuration was converted to a hemiarthroplasty configuration, due to failure of the glenoid components produced by the other manufacturer.The previously implanted components, including the smr reverse liner +6 mm d.40 mm (pn 1365.50.820, lot.23at2pj, ster.2400073), were explanted and following components were subsequently implanted: · smr finned stem, diameter 19 mm, length 80 mm (pn 1304.15.190); · smr 140° reverse humeral body (pn 1352.15.011); · smr adapter 36 mm for reverse body (pn 1352.15.200); · cta head, diameter 54 mm (pn 1323.09.540).The procedure was completed as intended.The patient is female, date of birth (b)(6) 1963.The event occurred in the united states.
Additional Manufacturer Narrative
Review of manufacturing records of the involved component has been performed and did not highlight any anomaly nor non-conformity on lot number 23at2pj.The manufacturer will submit a final report as soon as investigation is completed.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: REVERSE 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: 25687434
• Report Number: 3008021110-2026-00258
• Device Sequence Number: 21260201
• Product Code: PHX
• UDI-Device Identifier: 08033390102940
• UDI-Public: 8033390102940
• Combination Product (Y/N): N
• PMA/510(K) Number: K142139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/01/2026

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: 1365.50.820
• Device Lot Number: 23AT2PJ
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2026
• 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: 63 YR
• Patient Sex: Female