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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AEQUALIS REVERSED GLENOID SPHERE; SHOULDER JOINT METAL PROSTHESIS
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AEQUALIS REVERSED GLENOID SPHERE; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number DIAM.36MM TILTED 10° FOR 29MM BASEPLATE
Medical Device Problem Code Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Codes Awareness during Anaesthesia (1707); Failure of Implant (1924)
Date of Event 03/13/2020
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 glenoidsphere could not be implanted as the central screw was blocked.Another glenoid sphere was used and the surgery was completed with a delay.
 
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.
 
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Brand Name
AEQUALIS REVERSED GLENOID SPHERE
Common Device Name
SHOULDER JOINT METAL PROSTHESIS
MDR Report Key10161693
Report Number3000931034-2020-00070
Device Sequence Number17034306
Product Code KWS
UDI-Device Identifier03700386935893
UDI-Public03700386935893
Combination Product (Y/N)N
Initial Reporter CountryFR
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) 05/19/2020
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 Lay User/Patient
Device Expiration Date11/27/2022
Device Model NumberDIAM.36MM TILTED 10° FOR 29MM BASEPLATE
Device Catalogue NumberDWD191
Device Lot Number7469AS
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/19/2020
Supplement Date Received by Manufacturer05/19/2020
Initial Report FDA Received Date06/17/2020
Supplement Report FDA Received Date07/23/2020
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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