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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS PERFORM GLENOID; SHOULDER JOINT POLYMER PROSTHESIS
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TORNIER S.A.S. AEQUALIS PERFORM GLENOID; SHOULDER JOINT POLYMER PROSTHESIS Back to Search Results
Model Number KEELED MODEL S40
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Muscle Weakness/Atrophy (1967)
Date of Event 08/21/2019
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
"it was reported that a patient underwent a revision surgery due to anterosuperior escape.Stem retained from previous surgery.Ascend flex anatomic total converted into ascend flex reversed.Patient id: (b)(6)".
 
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Brand Name
AEQUALIS PERFORM GLENOID
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 Key9079526
Report Number3000931034-2019-00134
Device Sequence Number19411396
Product Code KWS
UDI-Device Identifier03700386937590
UDI-Public03700386937590
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K111902
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2019
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/21/2019
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 NumberKEELED MODEL S40
Device Catalogue NumberDWE503
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/02/2019
Initial Report FDA Received Date09/17/2019
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 Age67 YR
Patient Weight52
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