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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S5-6LM/RL9MM PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

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SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S5-6LM/RL9MM PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 71422262
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Injury (2348)
Event Date 06/26/2019
Event Type  Injury  
Manufacturer Narrative

(b)(6).

 
Event Description

It was reported that a revision surgery was performed due to loosening of the tibial implant.

 
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Brand NameJOURNEY UNI TIBINRT S5-6LM/RL9MM
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
101 hessle road
101 hessle road, TN 38116
0447940038
MDR Report Key8765809
MDR Text Key150237049
Report Number1020279-2019-02616
Device Sequence Number1
Product Code HSX
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK061011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/29/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/06/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number71422262
Device LOT Number16EM04893
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 Received06/27/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/06/2019 Patient Sequence Number: 1
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