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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS ASCEND FLEX REVERSED INSERT; SHOULDER JOINT POLYMER PROSTHESIS
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TORNIER S.A.S. AEQUALIS ASCEND FLEX REVERSED INSERT; SHOULDER JOINT POLYMER PROSTHESIS Back to Search Results
Model Number 36MM +6MM A12.5°
Medical Device Problem Code Malposition of Device (2616)
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Date of Event 06/18/2019
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
After the surgery of ascend flex rsa, because the fixed position of the sphere was not good, scapular notching occurred in the affected area.Revision surgery performed on (b)(6) 2019.
 
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 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 Key8788850
Report Number3000931034-2019-00108
Device Sequence Number2321134
Product Code KWS
UDI-Device Identifier03700386940507
UDI-Public03700386940507
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K122698
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 07/03/2019
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 Model Number36MM +6MM A12.5°
Device Catalogue NumberDWF361B
Device Lot NumberAA8729
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/03/2019
Supplement Date Received by Manufacturer07/03/2019
Initial Report FDA Received Date07/15/2019
Supplement Report FDA Received Date12/23/2019
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;
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