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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AEQUALIS HUMERAL HEAD; SHOULDER JOINT METAL PROSTHESIS
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AEQUALIS HUMERAL HEAD; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number 52 X 23 MM
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); Joint Dislocation (2374)
Date of Event 04/29/2020
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
Patient was driving her car when she suddenly felt a 'knack' followed by an immediate pain.X-ray showed a disengagement of the reversed hemi adapter of the metaphysial component.Revision surgery performed on (b)(6) 2020.
 
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 HUMERAL HEAD
Common Device Name
SHOULDER JOINT METAL PROSTHESIS
MDR Report Key10086731
Report Number3000931034-2020-00065
Device Sequence Number14223399
Product Code KWS
UDI-Device Identifier03700386915581
UDI-Public03700386915581
Combination Product (Y/N)N
Initial Reporter CountryNL
PMA/510(K) Number
K994392
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 04/29/2020
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 Model Number52 X 23 MM
Device Catalogue NumberDWB253
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/29/2020
Supplement Date Received by Manufacturer04/29/2020
Initial Report FDA Received Date05/26/2020
Supplement Report FDA Received Date06/29/2020
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;
Patient Age73 YR
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