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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 ECC. 1.5
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 09/21/2019
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
On "(b)(6) 2019: a staphylococcal infection was found in the affected area, and a revision surgery was scheduled for (b)(6) 2019.".
 
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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 Key9235630
Report Number3000931034-2019-00150
Device Sequence Number11393959
Product Code KWS
UDI-Device Identifier03700386941054
UDI-Public03700386941054
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K122698
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/25/2019
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 No Information
Device Expiration Date02/14/2024
Device Model NumberTH 0 ECC. 1.5
Device Catalogue NumberDWF510
Device Lot Number2254AU
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/26/2019
Initial Report FDA Received Date10/24/2019
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 Age84 YR
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