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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AEQUALIS ASCEND FLEX HUMERAL HEAD; SHOULDER JOINT METAL PROSTHESIS
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AEQUALIS ASCEND FLEX HUMERAL HEAD; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number DIAM. 46MM HEIGHT 17MM ECC.1.5
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Joint Dislocation (2374)
Date of Event 07/29/2020
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 the initial surgery of aequalis perform glenoid tsa on (b)(6) 2019, the glenoid implant dislodged due to loosening.On (b)(6) 2020, a revision surgery was performed.After removal of the pegglenoid and the head implant, the 4b stem was left in place and replaced with rsa.A new insert (dwf361b), tray (dwf510), base plate (dwd170) and glenoid sphere (dwd180) were used.Note: the current report is linked to emdr form # 3000931034-2020-00103 (our reference comp-2020-1649).
 
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Brand Name
AEQUALIS ASCEND FLEX HUMERAL HEAD
Common Device Name
SHOULDER JOINT METAL PROSTHESIS
MDR Report Key10475988
Report Number3000931034-2020-00131
Device Sequence Number11494307
Product Code KWS
UDI-Device Identifier03700386940057
UDI-Public03700386940057
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K122698
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/03/2020
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 Date09/13/2022
Device Model NumberDIAM. 46MM HEIGHT 17MM ECC.1.5
Device Catalogue NumberDWF046
Device Lot NumberAB3726
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/03/2020
Initial Report FDA Received Date09/01/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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