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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 DIA. 42 MM TH. +9 MM 12,5°B
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Date of Event 01/26/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
 
Event or Problem Description
It was reported that a patient underwent revision surgery due to instability/dislocation.Stem, tray and insert were removed and replaced during surgery, baseplate and glenosphere remained the same from previous surgery (1st stage).
 
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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 Key6642655
Report Number3000931034-2017-00120
Device Sequence Number1305660
Product Code KWS
UDI-Device Identifier03700386940897
UDI-Public03700386940897
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 Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/18/2017
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 Physician
Device Model NumberDIA. 42 MM TH. +9 MM 12,5°B
Device Catalogue NumberDWF422B
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/18/2017
Initial Report FDA Received Date06/15/2017
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 Age74 YR
Patient Weight57
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