MAUDE Adverse Event Report: LimaCorporate S.p.A SMR System; SMR System - Reverse HP Lateralizing Liner Long Dia. 44mm

Model Number	1362.09.120
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
A revision surgery was performed on (b)(6) 2025 due to implant instability.The surgical approach was restricted in terms of lateralisation on the glenoid side due to the monoblock design of the custom glenoid.Different humeral options were trialled to achieve stability.The surgeon felt that the extension and long lateralised liner were providing excessive length without corresponding lateralisation, potentially contributing to instability.The extension and long lateralised liner were therefore removed and replaced with a long lateralised liner.Previous surgery was performed on (b)(6) 2025.The cmd 25-1154 implant (cmd 25-1154 monoblock glenoid, product code 9617.Pe.04z), which had been implanted on (b)(6) 2025, was not revised, together with the humeral body and the stem.The surgeon followed the standard surgical workflow for shoulder revision.The explanted components included: smr humeral extension + 9 mm (product code 1352.15.001, lot 2422607, ster.N.2400222).Smr reverse hp lat.Liner long (product code 1362.09.120, lot 2422590, ster.N.2400215).Patient is male, 81 years old.Event happened in australia.
Additional Manufacturer Narrative
Investigation: the explanted components will not return to the manufacturer.Checking the manufacturing charts of the involved lot #2422590, no pre-existing anomalies were found on the (b)(4) devices manufactured with the same lot #.This is the first complaint received for the involved lot #.A final mdr will be shared upon completion of the investigation.

• Brand Name: SMR System
• Common Device Name: SMR System - Reverse HP Lateralizing Liner Long Dia. 44mm
• Manufacturer (Section D): LimaCorporate S.p.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 50865350
• Report Number: 3008021110-2026-00385
• Device Sequence Number: 21501351
• Product Code: PHX
• UDI-Device Identifier: 08033390050036
• UDI-Public: 08033390050036
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K252352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial

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: 1362.09.120
• Device Catalogue Number: 1362.09.120
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown