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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS GLENOID BASE; SHOULDER JOINT POLYMER PROSTHESIS
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TORNIER S.A.S. AEQUALIS GLENOID BASE; SHOULDER JOINT POLYMER PROSTHESIS Back to Search Results
Model Number KEELED EXTRA LARGE
Medical Device Problem Code Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes Pain (1994); Patient Problem/Medical Problem (2688)
Date of Event 09/01/2016
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
It was reported that a patient complains of pain with activity and the xrays reveal a loose of glenoid component.Subject id: (b)(6).
 
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Brand Name
AEQUALIS GLENOID BASE
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 Key8353333
Report Number3000931034-2019-00029
Device Sequence Number19404992
Product Code KWS
UDI-Device Identifier03700386915444
UDI-Public03700386915444
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K994393
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2006
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/22/2019
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 Model NumberKEELED EXTRA LARGE
Device Catalogue NumberDWB213
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/30/2018
Initial Report FDA Received Date02/20/2019
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 Age58 YR
Patient Weight73
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