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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS ASCEND FLEX REVERSED TRAY; SHOULDER JOINT METAL PROSTHESIS
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TORNIER S.A.S. AEQUALIS ASCEND FLEX REVERSED TRAY; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number TH 0 ECC 1.5
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Date of Event 10/10/2019
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
"post-op control in july was good, in september patient complains pain and instability because of disassembled glenosphere causing polyethylene's wear.".
 
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
 
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Brand Name
AEQUALIS ASCEND FLEX REVERSED TRAY
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 Key9297501
Report Number3000931034-2019-00160
Device Sequence Number2132085
Product Code KWS
UDI-Device Identifier03700386941054
UDI-Public03700386941054
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K122698
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/10/2019
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 Date02/18/2024
Device Model NumberTH 0 ECC 1.5
Device Catalogue NumberDWF510
Device Lot Number2256AU
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/10/2019
Supplement Date Received by Manufacturer10/10/2019
Initial Report FDA Received Date11/08/2019
Supplement Report FDA Received Date03/10/2020
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;
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