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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. 1.5
Medical Device Problem Codes Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes Joint Disorder (2373); Joint Dislocation (2374)
Date of Event 06/12/2020
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
After this patient had a ascend flex reverse surgery on (b)(6) 2020, a dislocation occurred at the affected area.On (b)(6) 2020, an implant at the affected area was replaced and the surgery was finished.
 
Additional Manufacturer Narrative
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 ASCEND FLEX REVERSED TRAY
Common Device Name
SHOULDER JOINT METAL PROSTHESIS
MDR Report Key10249654
Report Number3000931034-2020-00084
Device Sequence Number14169320
Product Code KWS
UDI-Device Identifier03700386941054
UDI-Public03700386941054
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K122698
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 06/15/2020
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 Date02/03/2025
Device Model NumberTH 0, ECC. 1.5
Device Catalogue NumberDWF510
Device Lot Number2800AV
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/15/2020
Supplement Date Received by Manufacturer06/15/2020
Initial Report FDA Received Date07/09/2020
Supplement Report FDA Received Date08/12/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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