MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR ECCENT. GLENOSPHERE Ø 36MM; ECCENTRICAL GLENOSPHERE DIA. 36 MM

Model Number 1376.09.031

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Implant Pain (4561)

Event Date 10/11/2023

Event Type  Injury  

Event Description

Revision surgery performed on 11th october 2023 due to pain and nickel-metal allergy.The patient's shoulder prosthesis has been revised with the compassionate use device cmd 23-1224.The components involved in the revision surgery were the following: - smr reverse humeral body (product code 1352.15.010, lot 2214887, sterilization number 2200196) - smr reverse liner standard (product code 1360.50.810, lot 20at4ux, sterilization number 2100137) - smr eccent.Glenosphere ø 36mm (product code 1376.09.031, lot 2217722, sterilization number 2200224) - tt hybrid reverse baseplate #s (product code 1379.15.160, lot 2209111, sterilization number 2200136) the previous surgery was performed on december 5th 2022.Event happened in united states.

Manufacturer Narrative

The dhrs of the involved product codes and lot numbers have been checked, without finding any anomaly.A final report will be submitted once the investigation is complete.

• Brand Name: SMR ECCENT. GLENOSPHERE Ø 36MM
• Type of Device: ECCENTRICAL GLENOSPHERE DIA. 36 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: 18283678
• MDR Text Key: 329950748
• Report Number: 3008021110-2023-00134
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K163397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1376.09.031
• Device Lot Number: 2217722
• 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