MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; CONNECTOR WITH SCREW SMALL-R

Model Number	1374.15.305
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed on (b)(6) 2025 due to instability.Patient underwent a reverse total shoulder replacement on (b)(6) 2024.During original surgery following assembly was implanted: smr finned stem short dia17mm (pn 1304.15.017, lot 2410458, sterilization (b)(4)), smr 140° humeral body reverse (pn 1352.15.011, lot 2422030, sterilization (b)(4)), smr reverse liner +3mm (pn 1360.50.815, lot 24at30w, sterilization (b)(4)), smr metal back glenoid small-r (pn 1375.21.005, lot 2319076, sterilization (b)(4)), smr connector small-r (pn 1374.15.305, lot 2300890, sterilization (b)(4)), smr glenosphere dia36mm (pn 1374.09.111, lot 2325318, sterilization (b)(4)).Patient recently came into clinic reporting shoulder instability.The surgeon performed a revision procedure to remove the above-mentioned reverse liner, glenosphere and connector and replaced them with a new 36mm glenosphere (pn 1374.09.111) but with a +4mm lateralized connector (pn 1374.15.314) and a reverse limavit +3 liner (pn 1360.54.815).According to surgeon, the extra 4mm of lateralization will help patient's stability, as she has a large amount of adipose tissue on her side and chest that was causing force on the construct as the patient put her arm into adduction.Surgery was completed as intended.Patient is female, date of birth (b)(6) 1956.The event occurred in the united states.
Additional Manufacturer Narrative
Review of manufacturing and sterilization records for involved components did not identify any pre-existing anomaly or non-conformity that could have contributed to reported issue.The manufacturer will submit a final report as soon as the investigation is completed.

• Brand Name: SMR SHOULDER
• Common Device Name: CONNECTOR WITH SCREW SMALL-R
• 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: 24322379
• Report Number: 3008021110-2026-00061
• Device Sequence Number: 9966490
• Product Code: PHX
• UDI-Device Identifier: 08033390002332
• UDI-Public: 8033390002332
• Combination Product (Y/N): N
• PMA/510(K) Number: K110598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 02/12/2026

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: 1374.15.305
• Device Lot Number: 2300890
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2026
• 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