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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP RT SZ 2; PRSTHSS,KNEEL,SEMI-CONSTRNED,CMNTD,POLYMER/METAL/POLYMER
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SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP RT SZ 2; PRSTHSS,KNEEL,SEMI-CONSTRNED,CMNTD,POLYMER/METAL/POLYMER Back to Search Results
Catalog Number 74022212
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Inflammation (1932)
Date of Event 10/29/2012
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that patient received kenalog injection/medrox due to pes anserinus tendonitis/ bursitis right knee.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.[(b)(4)].
 
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Brand Name
JOURNEY TIBIA BASE NP RT SZ 2
Common Device Name
PRSTHSS,KNEEL,SEMI-CONSTRNED,CMNTD,POLYMER/METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7072943
Report Number1020279-2017-01168
Device Sequence Number16174607
Product Code JWH
UDI-Device Identifier03596010554376
UDI-Public03596010554376
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K042515
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 03/13/2018
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 Health Professional
Device Expiration Date03/11/2021
Device Catalogue Number74022212
Device Lot Number11CM08835
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/29/2017
Supplement Date Received by Manufacturer09/29/2017
Initial Report FDA Received Date11/30/2017
Supplement Report FDA Received Date03/13/2018
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; Required Intervention;
Patient Age58 YR
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