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

Model Number	1376.09.041
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	01/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explanted components have been discarded therefore cannot be returned to manufacturer for analysis.Review of manufacturing and sterilization record did not highlight any anomaly on involved batches.Complaint database review for involved lot and sterilization number identified only one further complaint on the same batch out of total 56 manufactured units.Review of results of microbiological tests for clean room confirmed no deviation in sterilization process, thus excluding a manufacturing issue.Through follow-up communication it was learned that patient did not provide further information regarding rehabilitation and post-op therapy after original surgery, neither x-rays or lab results were shared.Taking into account that: - no further information is available regarding the nature of infection since lab reports have not been shared; - explanted components won't be returned; - no deviation in manufacturing and sterilization records has been found, the manufacturer has no evidence to consider this event as product related.According to the available pms data, the revision rate of smr glenosphere belonging to the family product codes 1374.09.Xxx, 1374.15.Xxx, 1376.09.Xxx, 1376.15.Xxx due to infection is around 0.06%.Based on the investigation performed, no corrective actions is required for this specific case.The manufacturer will continue monitoring the market to promptly detect any further similar issue.Note: this is a combined initial-final mdr.
Event or Problem Description
Revision surgery was performed on (b)(6) 2026 due to infection.Previous surgery was performed on (b)(6) 2025 and following components were implanted: - reverse liner (pn 1365.50.810, lot.23at07n, ster.(b)(4)) - tt augmented 360 baseplates (pn 1375.15.515, lot.2515952, ster.(b)(4)) - 140° humeral body (pn 1352.15.051, lot.2523962, ster.(b)(4)) - glenosphere eccentrical dia 40mm (pn 1376.09.041, lot.2022366, ster.(b)(4)) - connector lat + 2mm + screw (pn 1374.15.312, lot.2525197, ster.(b)(4)) - finned stem (pn 1304.15.022, lot.2327598, ster.(b)(4)) - glenoid peg tt (pn 1375.14.652) - bone screw (pn 8420.15.020) - bone screw (pn 8420.15.010) during revision almost all pre-existing components were removed and new retentive liner +3mm (pn 1361.50.810), tt augmented 360 baseplate (pn1375.15.565), 140° humeral body (pn 1352.15.051), connector lat 4mm + screw (pn1374.15.314), glenosphere dia 36 mm (pn 1374.09.111) and bone screws (pn 8420.15.010, pn 8420.15.020, 8420.15.030) were implanted.Wound was irrigated and a tissue sample was sent for analysis.Surgery was completed as intended.Patient is male, date of birth (b)(6) 1958.Event occurred in united states.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: ECCENTRICAL 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: 24638409
• Report Number: 3008021110-2026-00144
• Device Sequence Number: 9760853
• Product Code: PHX
• UDI-Device Identifier: 08033390123112
• UDI-Public: 8033390123112
• Combination Product (Y/N): N
• PMA/510(K) Number: K163397
• 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): 03/19/2026

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: 1376.09.041
• Device Lot Number: 2022366
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2026
• 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: 67 YR
• Patient Sex: Male