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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 4; PRSTHSS,KNE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR
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SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP RT SZ 4; PRSTHSS,KNE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR Back to Search Results
Catalog Number 74022214
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 09/14/2015
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that an aspiration of the right knee was performed due to infection and inflammation reaction.
 
Additional Manufacturer Narrative
Following receipt of additional information concerning this case it has been determined that the initial report was submitted in error.Please therefore disregard this report.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
 
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Brand Name
JOURNEY TIBIA BASE NP RT SZ 4
Common Device Name
PRSTHSS,KNE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7206140
Report Number1020279-2018-00063
Device Sequence Number16437655
Product Code JWH
UDI-Device Identifier03596010554284
UDI-Public03596010554284
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K042515
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 01/29/2018
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 Date07/11/2024
Device Catalogue Number74022214
Device Lot Number14GM08095
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/28/2017
Supplement Date Received by Manufacturer12/28/2017
Initial Report FDA Received Date01/19/2018
Supplement Report FDA Received Date01/29/2018
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 Age74 YR
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