MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER SYSTEM; LINER FOR METAL-BACK (UHMWPE) LINER STANDARD

Model Number	1377.50.010
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	03/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of manufacturing and sterilization record did not highlight any anomaly on involved batches.The manufacturer will submit a final report as soon as the investigation is completed.
Event or Problem Description
Revision surgery occurred on (b)(6) 2026, due to infection.During the revision all pre-existing components has been explanted: smr cementless finned stem (pn 1304.15.200, lot.2102987, ster.2100108); smr humeral head d.48 h.16mm (pn 1321.09.481, lot.2101790, ster.2100079); smr ecc.Adaptor taper standard (pn 1330.15.274, lot.2115996, ster.2100280); smr finned humeral body (pn 1350.15.110, lot.2114697, ster.2100274); smr metal-back glenoid std (pn 1375.21.010, lot.2100627, ster.2100093); liner f.Met.Back glen.Standard (pn 1377.50.010, lot.21at1aa, ster.2100306); bone screw ø6,5 h.30mm (pn 8420.15.030, lot.2120657, ster.2100314); bone screw ø6,5 h.30mm (pn 8420.15.030, lot.2121636, ster.2100334).And following new components have been implanted: finned stem dia.21mm l.80mm (pn 1304.15.210); finned humeral body medium (pn 1350.15.110); eccentrical 4mm adaptor taper (pn 1330.15.274); humeral head dia.50 h.21mm (pn 1324.09.501).Surgery has been completed as intended.Previous surgery was performed on (b)(6) 2021.Patient is female, date of birth: (b)(6)1953.Event occurred in the united states.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: LINER FOR METAL-BACK (UHMWPE) LINER 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: 25200761
• Report Number: 3008021110-2026-00210
• Device Sequence Number: 10096423
• Product Code: PHX
• UDI-Device Identifier: 08033390002608
• UDI-Public: 8033390002608
• Combination Product (Y/N): N
• PMA/510(K) Number: K113254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 05/18/2026

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: 1377.50.010
• Device Lot Number: 21AT1AA
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2026
• 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: 73 YR
• Patient Sex: Female