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: TORNIER S.A.S. AEQUALIS ASCEND FLEX REVERSED STEM; 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
 

TORNIER S.A.S. AEQUALIS ASCEND FLEX REVERSED STEM; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number SIZE 1B A 432.5° LENGTH 66MM
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Pain (1994)
Date of Event 07/13/2018
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 for persistent shoulder pain.Patient id: (b)(64).
 
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AEQUALIS ASCEND FLEX REVERSED STEM
Common Device Name
SHOULDER JOINT METAL PROSTHESIS
Manufacturer (Section D)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint-martin, 38330
FR  38330
MDR Report Key8128331
Report Number3000931034-2018-00175
Device Sequence Number1770263
Product Code KWS
UDI-Device Identifier03700386944482
UDI-Public03700386944482
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K122698
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 11/07/2018
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 Date12/31/2018
Device Model NumberSIZE 1B A 432.5° LENGTH 66MM
Device Catalogue NumberDWF601B
Device Lot Number5818AN
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/07/2018
Supplement Date Received by Manufacturer11/07/2018
Initial Report FDA Received Date12/04/2018
Supplement Report FDA Received Date11/08/2019
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 Age49 YR
-
-