MAUDE Adverse Event Report: LIMACORPORATE SPA SMR GLENOSPHERE Ø36MM SMALL-R

Model Number 1376.09.025

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2019

Event Type  malfunction  

Manufacturer Narrative

By checking the manufacturing chart of the lot #1903220, no anomaly was found on a total of 20 ecc.Glenospheres dia.36mm manufactured with the same lot#.Moreover, a total of 13 out of 20 ecc.Glenospheres with the same lot# were implanted without receiving additional complaints.We will submit a final report once the investigation will be completed.

Event Description

During surgery occurred on the (b)(6) 2019, a standard glenosphere dia.36mm with code 1374.09.105, lot# 1819441 was found in the package of a smr ecc.Glenosphere ø36mm small-r code 1376.09.025 lot #1903220 (ecc.Glenosphere dia.36mm small-r was the component originally planned to be implanted).Eventually, surgeon decided to open a new glenosphere with lot# 1374.09.105 and surgery was correctly completed.Only few minutes of prolonged surgery time reported as a consequence of the issue.Event occurred in (b)(6).

• Brand Name: SMR GLENOSPHERE Ø36MM SMALL-R
• Type of Device: SMR GLENOSPHERE Ø36MM SMALL-R
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer Contact: federica ; via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 8695553
• MDR Text Key: 149795375
• Report Number: 3008021110-2019-00067
• Device Sequence Number: 1
• Product Code: KWS
• 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
• Type of Report: Initial
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1376.09.025
• Device Lot Number: 1903220
• Date Manufacturer Received: 06/06/2019
• 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