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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS PRESS-FIT HUMERAL STEM; SHOULDER JOINT METAL PROSTHESIS
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TORNIER S.A.S. AEQUALIS PRESS-FIT HUMERAL STEM; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number DWB713
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Date of Event 05/10/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.
 
Event or Problem Description
It was reported that a patient underwent a revision surgery after 12 years for loosening/lysis.Conversion to rsa.
 
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Brand Name
AEQUALIS PRESS-FIT HUMERAL STEM
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 Key6629413
Report Number3000931034-2017-00122
Device Sequence Number10975101
Product Code KWS
UDI-Device Identifier03700386915741
UDI-Public03700386915741
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K980244
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2005
Device Explanted Year2017
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/10/2017
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 Physician
Device Model NumberDWB713
Device Catalogue Number9MM X 115MM 135°
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/10/2017
Initial Report FDA Received Date06/09/2017
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 Age71 YR
Patient Weight91
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