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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/26/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Dissociation between humeral components (between stem and/or tray and/or insert) patient id: (b)(6).

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 ASCEND FLEX TRAY
• Type of Device: SHOULDER JOINT METAL PROSTHESIS
• MDR Report Key: 9922274
• MDR Text Key: 186381295
• Report Number: 3000931034-2020-00047
• Device Sequence Number: 1
• Product Code: KWS
• 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: 03/06/2020

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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 68