MAUDE Adverse Event Report: LIMACORPORATE S.P.A. TT AUGM.360 BASEPLATE #S-R+4MM; SMR TT AUGMENTED 360 BASEPLATE S-R +4MM

Model Number 1375.15.524

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

By checking the dhr of the lot #1905870, #2010971, #2008604, and #2001631, no pre-existing anomaly was detected on all the components manufactured with these lot #s.This is the first and only complaint received on these lot numbers.We will submit a final mdr once the investigation will be completed.

Event Description

Intra-op event occurred during a shoulder surgery performed on (b)(6) 2020, in which the tt glenoid peg dissociated from the augmented 360 baseplate.During glenosphere implantation, a retractor came loose and pushed the glenosphere off the connector.The connector was stuck in the augmented 360 baseplate.In order to put the glenosphere on, the screws were removed and the taper remover was used to separate the augmented 360 baseplate from the tt glenoid peg.The following components were removed: smr connector small r (product code (b)(4), lot# 1905870 - ster.1900153); smr glenoid peg tt small-r (product code (b)(4), lot# 2010971 - ster.2000256); tt augmented 360 baseplate (product code (b)(4), lot# 2008604 - ster.2000192); smr eccentric glenosphere ø 40mm (product code 1376.09.041, lot# 2001631 - ster.2000100) new tt glenoid peg, augmented 360 baseplate, connector and glenosphere were implanted with the peripheral screws.Surgery prolonged of 30 minutes.Patient is a female, (b)(6) years old.

• Brand Name: TT AUGM.360 BASEPLATE #S-R+4MM
• Type of Device: SMR TT AUGMENTED 360 BASEPLATE S-R +4MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 10626795
• MDR Text Key: 213707220
• Report Number: 3008021110-2020-00082
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• PMA/PMN Number: K191746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1375.15.524
• Device Catalogue Number: 1375.15.524
• Device Lot Number: 2008604
• 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