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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED SHOULDER PROSTHESIS GLENOID SPHERE; SHOULDER JOINT METAL PROSTHESIS
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TORNIER S.A.S. AEQUALIS REVERSED SHOULDER PROSTHESIS GLENOID SPHERE; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number DIA.42 CENTERED
Medical Device Problem Code Disassembly (1168)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 08/31/2016
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 revision surgery due to glenosphere dissociation and instability/dislocation.Tray and poly also removed.Stem and baseplate remained from previous surgery.
 
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Brand Name
AEQUALIS REVERSED SHOULDER PROSTHESIS 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 Key6253643
Report Number3000931034-2017-00041
Device Sequence Number830747
Product Code KWS
UDI-Device Identifier03700386935855
UDI-Public03700386935855
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 Explanted Year2016
Reporter Type Manufacturer
Report Source study
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/20/2016
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? Yes
Operator of Device Health Professional
Device Model NumberDIA.42 CENTERED
Device Catalogue NumberDWD183
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/20/2016
Initial Report FDA Received Date01/16/2017
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 Age54 YR
Patient Weight76
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