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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIVACIT-E ART SURF SZ 3 8MM PROSTSIS KNE PATLOFMOROTIBIAL SMICONSTRIND CMNTD POLYMR ADTIVMTALPOLYMR ADTIV

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SMITH & NEPHEW, INC. VIVACIT-E ART SURF SZ 3 8MM PROSTSIS KNE PATLOFMOROTIBIAL SMICONSTRIND CMNTD POLYMR ADTIVMTALPOLYMR ADTIV Back to Search Results
Catalog Number 00584209308
Device Problem Incomplete or Inadequate Connection (4037)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/15/2019
Event Type  malfunction  
Event Description
It was reported that during surgery, the poly would not stay locked in the tibial base. Delay of less than 30 minutes, no injury reported. No backup device available, procedure was concluded with a poly one bigger size.
 
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Brand NameVIVACIT-E ART SURF SZ 3 8MM
Type of DevicePROSTSIS KNE PATLOFMOROTIBIAL SMICONSTRIND CMNTD POLYMR ADTIVMTALPOLYMR ADTIV
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key9029461
MDR Text Key158171240
Report Number1020279-2019-03347
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122529
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00584209308
Device Lot Number64045826
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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