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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED UNION SCREW; SHOULDER JOINT METAL PROSTHESIS
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TORNIER S.A.S. AEQUALIS REVERSED UNION SCREW; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number METAPHYSIS UNION SCREW
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Pain (1994)
Date of Event 08/06/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
 
Event or Problem Description
"it was reported that a patient underwent a revision surgery for pain 3 years post-operative.(b)(6)".
 
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
 
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Brand Name
AEQUALIS REVERSED UNION SCREW
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 Key7933627
Report Number3000931034-2018-00140
Device Sequence Number16728963
Product Code KWS
UDI-Device Identifier03700386931666
UDI-Public03700386931666
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K081059
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2018
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 09/05/2018
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 No Information
Device Expiration Date02/28/2018
Device Model NumberMETAPHYSIS UNION SCREW
Device Catalogue NumberDWD054
Device Lot Number2747AM
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/05/2018
Supplement Date Received by Manufacturer09/05/2018
Initial Report FDA Received Date10/04/2018
Supplement Report FDA Received Date02/26/2019
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 Weight76
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