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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AEQUALIS REVERSED FRACTURE PLUG; SHOULDER JOINT METAL PROSTHESIS
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AEQUALIS REVERSED FRACTURE PLUG; SHOULDER JOINT METAL PROSTHESIS Back to Search Results
Model Number METAPHYSEAL PLUG
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Joint Dislocation (2374)
Date of Event 04/23/2020
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
On (b)(6) 2020, the initial surgery of aequalis reversed fracture was performed.(b)(6) 2020, a dislocation occurred at the affected part.Operation was performed on (b)(6) 2020.The metaphysical plug and insert have been removed and replaced with a new spacer ((b)(4)) and insert ((b)(4)).Since the patient was lying down and watching his tv with his elbows on, the surgeon thinks that he was structurally vulnerable to dislocation.
 
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 REVERSED FRACTURE PLUG
Common Device Name
SHOULDER JOINT METAL PROSTHESIS
MDR Report Key10095463
Report Number3000931034-2020-00067
Device Sequence Number11598723
Product Code KWS
UDI-Device Identifier03700386931871
UDI-Public03700386931871
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K082120
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 Other
Type of Report Initial,Followup
Report Date (Section B) 04/30/2020
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 No Information
Device Expiration Date11/18/2024
Device Model NumberMETAPHYSEAL PLUG
Device Catalogue NumberDWB010
Device Lot Number1180AV
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/30/2020
Supplement Date Received by Manufacturer04/30/2020
Initial Report FDA Received Date05/28/2020
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 Age86 YR
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