MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR ECCENT. GLENOSPHERE Ø 40MM; SMR SHOULDER SYSTEM - ECCENTRICAL GLENOSPHERE DIA. 40 MM

Model Number 1376.09.041

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 12/29/2022

Event Type  Injury  

Event Description

Smr reverse revision surgery planned but not yet performed due to dislocation and pain.According to the complaint source, patient has a very complicated clinical history: on (b)(6) 2022 patient presented with dislocation and open reduction was planned; on (b)(6) 2022 the open reduction with fracture repair was completed successfully.This event was registered as lima corporate complaint (b)(4) and reported to fda as mfr 3008021110-2022-00111.On (b)(6) 2022 patient presented with pain after post operative exercises.X-rays showed dislocation and signs of implant loosening; revision surgery performed on (b)(6) 2022.During the revision surgeon, surgeon commented he opted for a standard glenosphere to be implanted but the ideal component to be implanted would have been a compassionate use device component (hp reverse glenosphere).This event is registered as lima corporate complaint (b)(4) and was reported to fda as mfr 3008021110-2022-00110.Smr reverse revision surgery planned but not yet performed due to dislocation and pain (object of this report).Event happened in us.

Manufacturer Narrative

We will send a final incident report once the investigation will be completed.

• Brand Name: SMR ECCENT. GLENOSPHERE Ø 40MM
• Type of Device: SMR SHOULDER SYSTEM - ECCENTRICAL GLENOSPHERE DIA. 40 MM
• 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: 16066770
• MDR Text Key: 306317818
• Report Number: 3008021110-2022-00139
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K142139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/13/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1376.09.041
• Device Lot Number: 2201497
• Is the Reporter a Health Professional?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male