MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR - TRIAL FINNED STEM 13; FINNED TRIAL STEM DIA.13MM

Model Number 9013.04.130

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

By checking the dhr of the lot #17af00x and #14aa370, no pre-existing anomalies were detected on the pieces manufactured with these lot #s.We will submit a final mdr once the investigation will be completed.

Event Description

During shoulder surgery performed on (b)(6) 2021, the smr - trial finned stem ø13 (product code 9013.04.130, lot# 17af00x) cold welded into the smr - stem extractor (product code 9013.02.301, lot# 14aa370).According to the reported information, surgeon implanted the final stem without trialing.Surgery prolonged of 15 minutes.Event happened in the us.

• Brand Name: SMR - TRIAL FINNED STEM 13
• Type of Device: FINNED TRIAL STEM DIA.13MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 11649016
• MDR Text Key: 266408681
• Report Number: 3008021110-2021-00029
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9013.04.130
• Device Lot Number: 17AF00X
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other