MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; HUMERAL HEADS (COCRMO) DIA.44MM

Model Number	1322.09.440
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	01/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explanted components were discarded therefore not available for identification and investigation.Lot number is unknown thus no review of manufacturing records can be performed for involved parts.From follow-up communication with sales representative it was confirmed that lot numbers cannot be retrieved and no information regarding cultures results were made available by hospital.The manufacturer will provide a final report as soon as the investigation is completed.
Event or Problem Description
Revision surgery performed on (b)(6) 2026.Patient presented with possible infection and instability.Previous surgery was performed on (b)(6) 2022, however no complete information regarding original implant was provided.During revision the surgeon removed the pre-existing liner for metal back glenoid std (part number: 1377.50.010), smr finned humeral body (part number: 1350.15.110), smr eccentrical adaptor taper std (part number: 1330.15.274) and smr humeral head dia44mm (part number: 1322.09.440), and converted the prosthesis to a reverse configuration using a connector (pn: 1375.15.310), glenosphere dia 36mm (pn: 1374.09.111), humeral reverse body 140° (pn: 1352.15.015) and reverse liner +3mm dia36mm (pn: 1360.54.815).Surgery was completed as intended.Patient is male, date of birth on (b)(6) 1962.The event occurred in the united states.

• Brand Name: SMR SHOULDER
• Common Device Name: HUMERAL HEADS (COCRMO) DIA.44MM
• 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: 24442716
• Report Number: 3008021110-2026-00121
• Device Sequence Number: 21423627
• Product Code: KWT
• UDI-Device Identifier: 08033390274074
• UDI-Public: 8033390274074
• Combination Product (Y/N): N
• PMA/510(K) Number: K100858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 02/25/2026

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: 1322.09.440
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2026
• 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: Male