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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED SHOULDER PROSTHESIS LATERALIZED INSERT; SHOULDER JOINT POLYMER PROSTHESIS
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TORNIER S.A.S. AEQUALIS REVERSED SHOULDER PROSTHESIS LATERALIZED INSERT; SHOULDER JOINT POLYMER PROSTHESIS Back to Search Results
Model Number CONSTRAINED 36MM
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Date of Event 03/09/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
 
Event or Problem Description
Sometime after surgery (type of shoulder surgery is unknown), patient was treated for shoulder dislocation.The patient was likely to have shoulder dislocation again so the insert and glenoid sphere were replaced with new ones.
 
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
 
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Brand Name
AEQUALIS REVERSED SHOULDER PROSTHESIS LATERALIZED INSERT
Common Device Name
SHOULDER JOINT POLYMER PROSTHESIS
Manufacturer (Section D)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint martin, 38330
FR  38330
MDR Report Key6563239
Report Number3000931034-2017-00108
Device Sequence Number10792821
Product Code KWS
UDI-Device Identifier03700386932694
UDI-Public03700386932694
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K081059
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 04/13/2017
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 NumberCONSTRAINED 36MM
Device Catalogue NumberDWD984
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 04/13/2017
Supplement Date Received by Manufacturer04/13/2017
Initial Report FDA Received Date05/12/2017
Supplement Report FDA Received Date02/27/2018
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 Age76 YR
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