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

Model Number SIZE 1B - 132.5° - 66MM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Joint Disorder (2373); Joint Dislocation (2374)

Event Date 06/12/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

After this patient had a ascend flex reverse surgery on (b)(6) 2020, a dislocation occurred at the affected area.On (b)(6) 2020, an implant at the affected area was replaced and the surgery was finished.

Manufacturer Narrative

The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.

• Brand Name: AEQUALIS ASCEND FLEX HUMERAL STEM
• Type of Device: SHOULDER JOINT METAL PROSTHESIS
• MDR Report Key: 10249649
• MDR Text Key: 198087801
• Report Number: 3000931034-2020-00082
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386944482
• UDI-Public: 03700386944482
• Combination Product (y/n): N
• PMA/PMN Number: K122698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SIZE 1B - 132.5° - 66MM
• Device Catalogue Number: DWF601B
• Device Lot Number: AC4176
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other