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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AEQUALIS ASCEND FLEX REVERSED TRAY; SHOULDER JOINT METAL PROSTHESIS
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AEQUALIS ASCEND FLEX REVERSED TRAY; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number TH 0 ECC 0
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 11/07/2019
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
Disassociation of the distal stem and the proximal body of aequalis ascend flex revive components visualized on post-op x-ray.Preliminary analysis shows that the issue is not related to aequalis ascend flex components but rather to aequalis flex revive components disassociation (tornier inc components).
 
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Brand Name
AEQUALIS ASCEND FLEX REVERSED TRAY
Common Device Name
SHOULDER JOINT METAL PROSTHESIS
MDR Report Key9430523
Report Number3000931034-2019-00174
Device Sequence Number484790
Product Code KWS
UDI-Device Identifier03700386941030
UDI-Public03700386941030
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K122698
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/07/2019
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 Date03/11/2024
Device Model NumberTH 0 ECC 0
Device Catalogue NumberDWF500
Device Lot Number2262AU
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/07/2019
Initial Report FDA Received Date12/06/2019
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;
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