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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS ASCEND FLEX SHOULDER SYSTEM; AEQUALIS ASCEND FLEX HUMERAL STEM
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TORNIER S.A.S. AEQUALIS ASCEND FLEX SHOULDER SYSTEM; AEQUALIS ASCEND FLEX HUMERAL STEM Back to Search Results
Model Number LONG CEMENTED SIZE 2B
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 06/09/2016
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
Revision surgery for humerus peri-prosthetic fracture.Non healed and increased pain despite bone simulator.Revision orif and strut graft.Greater and lesser tuberosity repair.(b)(6).
 
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Brand Name
AEQUALIS ASCEND FLEX SHOULDER SYSTEM
Common Device Name
AEQUALIS ASCEND FLEX HUMERAL STEM
Manufacturer (Section D)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint martin, 38330
FR  38330
MDR Report Key5906201
Report Number3000931034-2016-00124
Device Sequence Number10927092
Product Code KWS
UDI-Device Identifier03700386945328
UDI-Public03700386945328
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 Year2015
Device Explanted Year2016
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/11/2016
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 Health Professional
Device Model NumberLONG CEMENTED SIZE 2B
Device Catalogue NumberDWF712B
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/11/2016
Initial Report FDA Received Date08/26/2016
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 Age60 YR
Patient Weight102
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