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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE; SHOULDER JOINT METAL PROSTHESIS
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TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number 10° TILTED 42MM
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Type of Reportable Event Malfunction
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 instability/dislocation.Glenosphere was replaced during surgery, the other components remained the same from previous surgery (2nd stage of 2nd revision surgery see mdr # 3000931034-2017-00118, mdr # 3000931034-2017-00119, mdr # 3000931034-2017-00120).
 
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Brand Name
AEQUALIS REVERSED GLENOSPHERE
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 Key6642975
Report Number3000931034-2017-00121
Device Sequence Number953668
Product Code KWS
UDI-Device Identifier03700386935923
UDI-Public03700386935923
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 Year2016
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/18/2017
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 Number10° TILTED 42MM
Device Catalogue NumberDWD194
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/18/2017
Initial Report FDA Received Date06/15/2017
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 Age74 YR
Patient Weight57
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