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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS PRESS FIT STEM; SHOULDER JOINT METAL PROSTHESIS
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TORNIER S.A.S. AEQUALIS PRESS FIT STEM; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number DIAM13 L125 ANGLE 130
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 07/12/2017
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 revision surgery due to loosening-lysis 13 years post-op.Patient id : (b)(6).
 
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Brand Name
AEQUALIS PRESS FIT 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 Key7048079
Report Number3000931034-2017-00181
Device Sequence Number13669097
Product Code KWS
UDI-Device Identifier03700386915819
UDI-Public03700386915819
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 Year2004
Device Explanted Year2017
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/20/2017
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 NumberDIAM13 L125 ANGLE 130
Device Catalogue NumberDWB732
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/20/2017
Initial Report FDA Received Date11/21/2017
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 Age80 YR
Patient Weight96
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