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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AEQUALIS ASCEND FLEX INSERT; SHOULDER JOINT POLYMER PROSTHESIS
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AEQUALIS ASCEND FLEX INSERT; SHOULDER JOINT POLYMER PROSTHESIS Back to Search Results
Model Number DIAM 36MM +6, A 12.5°
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 INSERT
Common Device Name
SHOULDER JOINT POLYMER PROSTHESIS
MDR Report Key10249652
Report Number3000931034-2020-00083
Device Sequence Number11479274
Product Code KWS
UDI-Device Identifier03700386940507
UDI-Public03700386940507
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 Date01/30/2025
Device Model NumberDIAM 36MM +6, A 12.5°
Device Catalogue NumberDWF361B
Device Lot NumberAC8260
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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