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 INSERT; SHOULDER JOINT POLYMER 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 INSERT; SHOULDER JOINT POLYMER PROSTHESIS Back to Search Results
Model Number DIAM36MM TH+6 ANGLE 12.5 B
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Date of Event 05/23/2018
Type of Reportable Event Serious Injury
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.
 
Event or Problem Description
"it was reported that a patient underwent a revision surgery for loosening/lysis at 10 months post-operative.Patient id: (b)(6)".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AEQUALIS ASCEND FLEX INSERT
Common Device Name
SHOULDER JOINT POLYMER PROSTHESIS
Manufacturer (Section D)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint-martin, 38330
FR  38330
MDR Report Key7694200
Report Number3000931034-2018-00087
Device Sequence Number13841278
Product Code KWS
UDI-Device Identifier03700386940507
UDI-Public03700386940507
Combination Product (Y/N)N
Initial Reporter StateMN
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
Report Date (Section B) 06/18/2018
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 No Information
Device Model NumberDIAM36MM TH+6 ANGLE 12.5 B
Device Catalogue NumberDWF361B
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/18/2018
Initial Report FDA Received Date07/17/2018
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 Age67 YR
Patient Weight69
-
-