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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS RESURFACING HEAD; SHOULDER JOINT METAL PROSTHESIS
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TORNIER S.A.S. AEQUALIS RESURFACING HEAD; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number 43X17 MM
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Joint Dislocation (2374)
Date of Event 11/07/2016
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 had an adverse event described as "subluxation/dislocation of the study shoulder related to seizure" 2 years after primary surgery.Patient id: (b)(6).
 
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Brand Name
AEQUALIS RESURFACING HEAD
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 Key9241728
Report Number3000931034-2019-00151
Device Sequence Number19306000
Product Code KWS
UDI-Device Identifier03700386926952
UDI-Public03700386926952
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K062661
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/27/2019
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 Health Professional
Device Expiration Date01/31/2013
Device Model Number43X17 MM
Device Catalogue NumberDWD805
Device Lot Number007
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/27/2019
Initial Report FDA Received Date10/25/2019
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 Age36 YR
Patient Weight84
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