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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 DIAM.39MM FOR BASEPLATE 25 ECC+2
Medical Device Problem Codes Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Date of Event 06/05/2018
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 revision surgery for dissociation 1 year 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 Key7681373
Report Number3000931034-2018-00083
Device Sequence Number1553868
Product Code KWS
UDI-Device Identifier03700386955112
UDI-Public03700386955112
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/15/2018
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 Model NumberDIAM.39MM FOR BASEPLATE 25 ECC+2
Device Catalogue NumberDWH906
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/15/2018
Initial Report FDA Received Date07/12/2018
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 Age62 YR
Patient Weight79
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