MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR SYSTEM; SMR SYSTEM - REVERSE HP LINER SHORT DIA. 40MM

Model Number	1365.09.010
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the device history records (dhrs) for the smr reverse hp liner short could not be completed because the lot number of the explanted device is unknown.A dhr review was therefore conducted for the associated lot numbers 2415046 and 2424342, no pre existing anomalies or non conformities were identified during the manufacturing processes of these lots.A final investigation report will be submitted once all activities are completed.
Event or Problem Description
Revision surgery performed on (b)(6) 2024 due to instability.The following devices were removed: smr cementless finned stem (product code: 1304.15.170, lot: 2415046 - ster: (b)(4), smr reverse humeral body short (product code: 1352.15.005, lot: 2424342 - ster: (b)(4), smr reverse hp liner short (product code: 1365.09.010, lot: unknown) , the devices finned stem (code: 1304.15.170), reverse lateralizing liner 40mm long (code: 1365.09.120) and short reverse humeral body (code: 1352.15.005) were implanted.Previous revision surgery was performed (b)(6) 2024.Patient: male, 82 years old.

• Brand Name: SMR SYSTEM
• Common Device Name: SMR SYSTEM - REVERSE HP LINER SHORT DIA. 40MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 24590262
• Report Number: 3008021110-2026-00161
• Device Sequence Number: 13144508
• Product Code: PHX
• UDI-Device Identifier: 08033390061254
• UDI-Public: 8033390061254
• Combination Product (Y/N): N
• PMA/510(K) Number: K243826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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: 1365.09.010
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/13/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown