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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 42MM FOR 25MM BASEPLATE
Medical Device Problem Code Disassembly (1168)
Health Effect - Clinical Codes Failure of Implant (1924); Patient Problem/Medical Problem (2688)
Date of Event 09/28/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
 
Event or Problem Description
(b)(6) 2017: initial rsa surgery was done./ (b)(6) 2017: glenoid sphere dislocation was found./(b)(6) 2017: glenoid sphere and insert were replaced.
 
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
 
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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 Key7048080
Report Number3000931034-2017-00186
Device Sequence Number13875769
Product Code KWS
UDI-Device Identifier03700386932731
UDI-Public03700386932731
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K081059
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/05/2017
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 Expiration Date05/31/2019
Device Model NumberDIAM 42MM FOR 25MM BASEPLATE
Device Catalogue NumberDWD183
Device Lot Number1289AO
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2017
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 10/05/2017
Supplement Date Received by Manufacturer10/05/2017
Initial Report FDA Received Date11/21/2017
Supplement Report FDA Received Date01/31/2018
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;
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