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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS ASCEND FLEX INSERT; SHOULDER JOINT POLYMER PROSTHESIS
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TORNIER S.A.S. AEQUALIS ASCEND FLEX INSERT; SHOULDER JOINT POLYMER PROSTHESIS Back to Search Results
Model Number DIAM 39MM +6 STD A. 12.5°
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Joint Dislocation (2374)
Date of Event 09/18/2019
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
"(b)(6) 2019: the first surgery of ascend flex rsa was performed.(b)(6) 2019: after the surgery, dislocation occurred in the affected area.".
 
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 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 Key9278761
Report Number3000931034-2019-00154
Device Sequence Number11446740
Product Code KWS
UDI-Device Identifier03700386940682
UDI-Public03700386940682
Combination Product (Y/N)N
Initial Reporter CountryJA
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) 10/07/2019
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 No Information
Device Expiration Date11/19/2023
Device Model NumberDIAM 39MM +6 STD A. 12.5°
Device Catalogue NumberDWF391B
Device Lot Number2394AU
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/07/2019
Supplement Date Received by Manufacturer10/07/2019
Initial Report FDA Received Date11/05/2019
Supplement Report FDA Received Date02/11/2020
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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