MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR GLENOID BASEPLATE STANDARD; SMR GLENOID BASEPLATE STANDARD (KWS-KWT)

Model Number 1375.15.610

Device Problem Separation Problem (4043)

Patient Problem No Code Available (3191)

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

By checking the dhrs of the involved components (peg lot# 1616465, baseplate lot# 1715029), no pre-existing anomaly was found on the 55 pegs and 30 baseplates placed on the market with the same lot#s.No other complaints received on these lot#s.We will proceed with further investigation and submit a final mdr once concluded.

Event Description

During shoulder revision surgery performed on (b)(6) 2019, while the surgeon was removing the glenosphere from the baseplate with short peg, the baseplate with code 1375.15.610 lot# 1715029 disassociated from the tt peg code 1375.14.661 lot# 1616465, creating a defect in patient's glenoid and causing 45 mins of prolonged surgery time.The surgeon resolved this issue by implanting another tt baseplate with a longer peg.Event happened in usa.The revision surgery was also reported to fda as lima complaint #346/19 (fda ref: 3008021110-2019-00128).

• Brand Name: SMR GLENOID BASEPLATE STANDARD
• Type of Device: SMR GLENOID BASEPLATE STANDARD (KWS-KWT)
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 9309605
• MDR Text Key: 204702296
• Report Number: 3008021110-2019-00125
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K133349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1375.15.610
• Device Lot Number: 1715029
• 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): Hospitalization