MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; SMR 3-PEGS SMALL

Model Number	1379.50.020
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Loose body in joint (4926)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2025 due to loosening/disassembly of glenoid components.Patient underwent primary surgery in 2014 and received an anatomic shoulder replacement utilizing smr humeral components including: - smr humeral head dia 42mm (part number 1322.09.420), - smr ecc.Adaptor taper standard (part number 1330.15.272), - smr trauma humeral body #medium (part number 1350.15.010), and small 3-pegged cemented glenoid (part number 1379.50.020, lot unknown).Due to glenoid implant loosening over time, osteolysis caused significant amount of glenoid bone loss.Above-mentioned components were removed and demineralized bone matrice and cancellous bone chips were used to graft in the glenoid.New humeral body, adapter, and humeral head were implanted and patient currently has a hemiarthroplasty, until a second procedure can be undergone in the future to implant a baseplate.Patient is a female, date of birth (b)(6) 1948.The event occurred in the united states.
Additional Manufacturer Narrative
Explanted components have been discarded therefore cannot be returned to manufacturer for identification and investigation.No review of manufacturing records for complained parts is therefore possible.The manufacturer will provide a final report as soon as the investigation is completed.

• Brand Name: SMR SHOULDER
• Common Device Name: SMR 3-PEGS SMALL
• 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: 24018190
• Report Number: 3008021110-2026-00006
• Device Sequence Number: 9191528
• Product Code: KWS
• UDI-Device Identifier: 08033390096362
• UDI-Public: 8033390096362
• Combination Product (Y/N): N
• PMA/510(K) Number: K130642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• 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): 01/07/2026

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: 1379.50.020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2026
• 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 Sex: Unknown