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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S3-4LM/RL8MM PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

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SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S3-4LM/RL8MM PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 71422251
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2019
Event Type  Malfunction  
Event Description

It was reported that during surgery when implanting the insert, the insert could be easily placed in the tibial baseplate slot bare-handed (without the impactor). Also, testing with bent pliers, the insert could be easily taken out of the slot. Another insert of the same code was used, but the result was the same, and it was still left inside the patient. Since there was no revision instrument at that time and the surgeon could not guarantee the revision result, the suture wound treatment was selected at that time and the long-term postoperative situation of the patient was uncertain. There was a delay of 0-30 minutes reported.

 
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Brand NameJOURNEY UNI TIBINRT S3-4LM/RL8MM
Type of DevicePROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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 Key9478623
MDR Text Key177355462
Report Number1020279-2019-04417
Device Sequence Number1
Product Code HSX
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK061011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/25/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/17/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number71422251
Device Catalogue Number71422251
Device LOT Number19CM04664
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/06/2019
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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