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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS ASCEND FLEX TRAY; SHOULDER JOINT METAL PROSTHESIS
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TORNIER S.A.S. AEQUALIS ASCEND FLEX TRAY; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number TH +0 OFFSET 3.5 MM
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 10/09/2019
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
"it was reported that a patient underwent a revision surgery due to loosening/lysis 4 years after primary surgery.Patient id: (b)(6)".
 
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Brand Name
AEQUALIS ASCEND FLEX TRAY
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 Key9297508
Report Number3000931034-2019-00167
Device Sequence Number607492
Product Code KWS
UDI-Device Identifier03700386941078
UDI-Public03700386941078
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 Year2019
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/10/2019
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 NumberTH +0 OFFSET 3.5 MM
Device Catalogue NumberDWF520
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/10/2019
Initial Report FDA Received Date11/08/2019
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 Age72 YR
Patient Weight158
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