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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG VERILAST TITANIUM BILATERAL KNEES; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

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SMITH & NEPHEW ORTHOPAEDICS AG VERILAST TITANIUM BILATERAL KNEES; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL Back to Search Results
Device Problem Contamination (1120)
Patient Problem Insufficient Information (4580)
Event Date 04/20/2021
Event Type  Injury  
Event Description
My orthopedic during surgery dr.(b)(6) was brought a donor tissue, and blood from a man who had mugus (a blood disease which can turn into multiple myeloma an incurable cancer.) i had knee surgery, even though i signed the required forms, i never realized it would be the situation it's today.Sincerely, since, then (b)(6), and the advisor there have wanted the company stopped and closed down, but it's sad to say no one has explained it has stopped to me or dr.(b)(6).My name is (b)(6).Can you help i am the person and patient this happened to and deeply care about the community.I have been searching lately and found, i want to join in helping (b)(6) and anyone suffering from this situation.(b)(6).Fda safety report id# (b)(4).
 
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Brand Name
VERILAST TITANIUM BILATERAL KNEES
Type of Device
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS AG
MDR Report Key11982829
MDR Text Key255946330
Report NumberMW5101824
Device Sequence Number2
Product Code JWH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/08/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/10/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Disability;
Patient Age63 YR
Patient Weight105
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