MAUDE Adverse Event Report: AEQUALIS ASCEND FLEX STEM; SHOULDER JOINT METAL PROSTHESIS

Model Number STD PTC - SIZE 2B - 132.5° - 70MM

Device Problem Contamination (1120)

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

Event Date 01/07/2020

Event Type  Injury  

Manufacturer Narrative

This is the initial report submitted regarding this surgical event and medical device.

Event Description

"we noticed on the stem, after impacting tray, white blotchy.Didn't rub off.Decided to open a 3b stem after compacting new size.When 3b stem was opened we noticed plastic flecks on the stem.We wiped them off and impacted the tray on the new stem.After tray impaction we noticed these white marks again on both sides of the stem.We determined this was an issue with the impaction block mwf107.The 3b stem was implanted.No back up available.Had to open and compact for size up.Not the best size and fit.".

• Brand Name: AEQUALIS ASCEND FLEX STEM
• Type of Device: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer Contact: maud andriollo ; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• MDR Report Key: 9680602
• MDR Text Key: 178105004
• Report Number: 3000931034-2020-00005
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386944512
• UDI-Public: 03700386944512
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K122698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2024
• Device Model Number: STD PTC - SIZE 2B - 132.5° - 70MM
• Device Catalogue Number: DWF602B
• Device Lot Number: AC2568
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2019
• 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): Other