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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOID SPHERE; SHOULDER JOINT METAL PROSTHESIS
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TORNIER S.A.S. AEQUALIS REVERSED GLENOID SPHERE; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number 25MM SPHERE 2MM ECCENTRIC 36MM
Medical Device Problem Code Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 10/18/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
 
Event or Problem Description
Center locking screw of spheres were locked in spheres.Could not release the screw in any direction.60 minutes delayed.
 
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Brand Name
AEQUALIS REVERSED 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 Key9410140
Report Number3000931034-2019-00178
Device Sequence Number14485869
Product Code KWS
UDI-Device Identifier03700386935848
UDI-Public03700386935848
Combination Product (Y/N)N
Initial Reporter CountrySF
PMA/510(K) Number
K081059
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date08/09/2024
Device Model Number25MM SPHERE 2MM ECCENTRIC 36MM
Device Catalogue NumberDWD182
Device Lot Number7998AU
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/11/2019
Initial Report FDA Received Date12/04/2019
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 Age80 YR
Patient Weight74
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