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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED II GLENOID SPHERE; SHOULDER JOINT METAL PROSTHESIS
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TORNIER S.A.S. AEQUALIS REVERSED II GLENOID SPHERE; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number CENTERED DIAM; 36MM
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Date of Event 08/23/2016
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 underwent a closed reduction under anesthesia due to instability/dislocation, 3 months post-operative.Patient id: (b)(6).".
 
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Brand Name
AEQUALIS REVERSED II GLENOID SPHERE
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 Key8159453
Report Number3000931034-2018-00174
Device Sequence Number1973585
Product Code KWS
UDI-Device Identifier03700386940514
UDI-Public03700386940514
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) 11/16/2018
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 Date03/31/2021
Device Model NumberCENTERED DIAM; 36MM
Device Catalogue NumberDWD180
Device Lot Number0089AR
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/15/2018
Initial Report FDA Received Date12/13/2018
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 Age72 YR
Patient Weight121
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