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

Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Type of Reportable Event	Serious Injury

• Brand Name: SMR Shoulder System
• Common Device Name: SMR Reverse HP Liner Dia. 44mm Lateralizing - Medium
• Manufacturer (Section D): LimaCorporate S.p.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 50838573
• Report Number: 3008021110-2026-00377
• Device Sequence Number: 18711787
• Product Code: PHX
• UDI-Device Identifier: 08033390050029
• UDI-Public: 08033390050029
• 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
• 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: 09/21/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown