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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 REVERSED 36MM +9MM / 12.5 A
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 12/25/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
 
Event or Problem Description
"(b)(6) 2017: initial rsa surgery was done./ (b)(6) 2017: glenoid sphere dislocation was found.(the patient had been unable to lift her shoulder.) / (b)(6) 2017: glenoid sphere, baseplate, 4 screws, insert and tray were removed.Comments from surgeon: the patient's bone density had been very low which may have caused the glenoid sphere dislocation.".
 
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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 Key7233756
Report Number3000931034-2018-00006
Device Sequence Number19196377
Product Code KWS
UDI-Device Identifier03700386940538
UDI-Public03700386940538
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 Year2017
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/05/2018
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 Physician
Device Expiration Date11/10/2021
Device Model NumberREVERSED 36MM +9MM / 12.5 A
Device Catalogue NumberDWF362B
Device Lot NumberAA6282
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/05/2018
Initial Report FDA Received Date02/01/2018
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 Age77 YR
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