MAUDE Adverse Event Report: Limacorporate S.p.A SMR System; Humeral Body Trauma Short

Model Number	1350.15.030
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No pre-existing anomaly was detected by checking the manufacturing and sterilization charts of the lot numbers involved in the event.This is the first and only complaint we received with this lot number.We will submit a final report as soon as the investigation is complete.
Event or Problem Description
Revision surgery performed on (b)(6) 2025, due to glenoid loosening, bone loss and poor bone quality.The following components were removed: smr trauma hum.Body# short (part number: 1350.15.030, lot number: 2017188, sterilization: 2000339).Smr humeral head ø42 mm (part number: 1322.09.420, lot number: 1400754, sterilization: 2100055).Smr ecc.Adaptor taper standard (part number: 1330.15.274, lot number: 2124614, sterilization: 2200002).The patient previously had a total shoulder arthroplasty with lima components (smr stem, trauma body, eccentric adapter, humeral head, and 3-pegged cemented poly), though the initial surgery date is unknown.On (b)(6) 2024, the patient underwent a revision procedure for glenoid loosening.During the on (b)(6) surgery, the surgeon attempted to complete the second phase of the revision.The humeral stem, body, and head were removed.However, when trying to implant the baseplate for a reverse shoulder replacement, the soft glenoid bone cracked.To address this, the surgeon decided to reinforce the glenoid with bone graft and proceeded by placing an adapter and humeral head onto the reverse body, converting it into a hemiarthroplasty.The patient is a female, date of birth on (b)(6) 1952.The event happened in the united states.

• Brand Name: SMR System
• Common Device Name: Humeral Body Trauma Short
• 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: 21620230
• Report Number: 3008021110-2025-00015
• Device Sequence Number: 6706075
• Product Code: KWT
• UDI-Device Identifier: 08033390272506
• UDI-Public: 08033390272506
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K100858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2025

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: 1350.15.030
• Device Catalogue Number: 1350.15.030
• Device Lot Number: 2017188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 10/01/2026
• 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: Other
• Patient Age: 72 YR
• Patient Sex: Female