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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS ASCEND FLEX REVESERD INSERT; SHOULDER JOINT METAL PROSTHESIS
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TORNIER S.A.S. AEQUALIS ASCEND FLEX REVESERD INSERT; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number 36 MM +6 A12.5°
Medical Device Problem Code Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Date of Event 12/14/2018
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 a revision surgery due to loosening/lysis 3 years post-operative, with one broken multidirectional screw.Subject id: (b)(6).
 
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Brand Name
AEQUALIS ASCEND FLEX REVESERD INSERT
Common Device Name
SHOULDER JOINT METAL PROSTHESIS
Manufacturer (Section D)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint martin, 38330
FR  38330
MDR Report Key8239833
Report Number3000931034-2019-00007
Device Sequence Number13991810
Product Code KWS
UDI-Device Identifier03700386940507
UDI-Public03700386940507
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 Year2018
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/03/2018
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 Lay User/Patient
Device Model Number36 MM +6 A12.5°
Device Catalogue NumberDWF361B
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/14/2018
Initial Report FDA Received Date01/11/2019
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;
Patient Age74 YR
Patient Weight113
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