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 METAPHYSIS; 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 METAPHYSIS; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number CEMENTED 36MM
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Bone Fracture(s) (1870)
Date of Event 03/10/2020
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
It was reported that a patient underwent a revision surgery due to a periprosthetic fracture 8 years after previous surgery.Patient id: (b)(6).
 
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 METAPHYSIS
Common Device Name
SHOULDER JOINT METAL PROSTHESIS
MDR Report Key9942953
Report Number3000931034-2020-00054
Device Sequence Number11602607
Product Code KWS
UDI-Device Identifier03700386916328
UDI-Public03700386916328
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K030941
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2019
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 03/10/2020
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 Date09/01/2016
Device Model NumberCEMENTED 36MM
Device Catalogue NumberDWB960
Device Lot Number2536AL
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/10/2020
Supplement Date Received by Manufacturer03/10/2020
Initial Report FDA Received Date04/09/2020
Supplement Report FDA Received Date06/09/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age89 YR
Patient Weight60
-
-