MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SHOULDER SYSTEM; SHORT REVERSE HUMERAL BODY

Model Number	1352.15.005
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed on (b)(6) 2026 due to distal humerus fracture with consequent shoulder instability.Date of original surgery is unknown.During the revision surgery pre-existing smr short reverse humeral body (pn 1352.15.005) and smr reverse liner 36 mm + 6 (pn 1360.50.820) were explanted and replaced with new 140° short reverse humeral body (pn 1352.15.015) and reverse liner standard 36 mm (pn 1360.50.810).Revision was completed as intended.Patient is 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 analysis.Review of production records for complained components cannot be performed as lot number is unknown.The manufacturer will submit a final report as soon as the investigation is completed.

• Brand Name: SMR SHOULDER SYSTEM
• Common Device Name: SHORT REVERSE HUMERAL BODY
• 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: 24584226
• Report Number: 3008021110-2026-00132
• Device Sequence Number: 13041823
• Product Code: PHX
• UDI-Device Identifier: 08033390272551
• UDI-Public: 8033390272551
• Combination Product (Y/N): N
• PMA/510(K) Number: K110598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/12/2026

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: 1352.15.005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2026
• 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 Age: 77 YR
• Patient Sex: Female