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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED II BASE PLATE; SHOULDER JOINT METAL PROSTHESIS
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TORNIER S.A.S. AEQUALIS REVERSED II BASE PLATE; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number DIAM. 25 MM
Medical Device Problem Code Disassembly (1168)
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Date of Event 09/07/2017
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
The sphere and baseplate had become loosened and sphere and insert were replaced with new ones.The surgeon said that the screws in the sphere were not tightened enough at the initial operation.
 
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 BASE PLATE
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 Key7048097
Report Number3000931034-2017-00178
Device Sequence Number1159163
Product Code KWS
UDI-Device Identifier03700386935947
UDI-Public03700386935947
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) 09/14/2017
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 Date05/05/2022
Device Model NumberDIAM. 25 MM
Device Catalogue NumberDWD170
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 09/14/2017
Supplement Date Received by Manufacturer09/14/2017
Initial Report FDA Received Date11/21/2017
Supplement Report FDA Received Date03/22/2018
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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