MAUDE Adverse Event Report: LIMACORPORATE S.P.A. GLENOSPHERE - SMALL-R; SMR GLENOSPHERE Ø36MM SMALL-R

Model Number 1374.09.105

Device Problem Insufficient Information (3190)

Patient Problem Implant Pain (4561)

Event Date 02/22/2017

Event Type  Injury  

Event Description

Shoulder revision surgery performed on (b)(6) 2017, of smr reverse prothesis due to persistent pain, but no trauma reported.Previous surgery was performed on (b)(6) 2016.The following components got explanted: smr glenosphere ø36mm small-r (product code: 1374.09.105, lot.1518302 - (b)(4)) sold in us smr glenoid peg tt small-r #l (product code: 1375.14.653, lot.1515025 - (b)(4)) sold in us smr glenoid baseplate small-r (product code: 1375.15.650, lot.1517503 - (b)(4)) sold in us bone screw ø6,5 h.30mm (product code:8420.15.030, lot.1603541 - (b)(4)) sold in us.Event happened in united kingdom.

Manufacturer Narrative

Checking the manufacturing charts of the involved lot numbers, no pre-existing anomaly was found on the devices manufactured with the same lot numbers.We submit a final report when the investigation is complete.

• Brand Name: GLENOSPHERE - SMALL-R
• Type of Device: SMR GLENOSPHERE Ø36MM SMALL-R
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 18683486
• MDR Text Key: 335074403
• Report Number: 3008021110-2024-00005
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K110598
• 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: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1374.09.105
• Device Lot Number: 1518302
• Date Manufacturer Received: 01/08/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention