Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AEQUALIS REVERSED GLENOID SPHERE; SHOULDER JOINT METAL PROSTHESIS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AEQUALIS REVERSED GLENOID SPHERE; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number DIAM. 39MM CENTERED FOR 25MM BASEPLATE
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 06/16/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
 
Event or Problem Description
On (b)(6) 2019, the initial surgery for ascend flex reverse was performed.After this surgery, the affected area was found to be infected.The revision surgery was performed on (b)(6) 2020.After cleaning the affected area, only the glenoid sphere was replaced with the same product number and the surgery was completed.
 
Additional 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AEQUALIS REVERSED GLENOID SPHERE
Common Device Name
SHOULDER JOINT METAL PROSTHESIS
MDR Report Key10288146
Report Number3000931034-2020-00087
Device Sequence Number19698554
Product Code KWS
UDI-Device Identifier03700386955075
UDI-Public03700386955075
Combination Product (Y/N)N
Initial Reporter CountryJA
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 06/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Expiration Date07/17/2022
Device Model NumberDIAM. 39MM CENTERED FOR 25MM BASEPLATE
Device Catalogue NumberDWH904
Device Lot Number7805AS
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/17/2020
Supplement Date Received by Manufacturer06/17/2020
Initial Report FDA Received Date07/17/2020
Supplement Report FDA Received Date07/28/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
-
-