MAUDE Adverse Event Report: AEQUALIS HUMERAL HEAD; SHOULDER JOINT METAL PROSTHESIS

Model Number COCR 48X18 MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/03/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Dr.(b)(6) explanted the glenoid, the humeral head and humeral stem.He commented on the significant wear of the glenoid.

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.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 HUMERAL HEAD
• Type of Device: SHOULDER JOINT METAL PROSTHESIS
• MDR Report Key: 9920219
• MDR Text Key: 186277363
• Report Number: 3000931034-2020-00042
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386915543
• UDI-Public: 03700386915543
• Combination Product (y/n): N
• PMA/PMN Number: K994392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/13/2014
• Device Model Number: COCR 48X18 MM
• Device Catalogue Number: DWB248
• Device Lot Number: 3789AI
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other