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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 7; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
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SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP RT SZ 7; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED Back to Search Results
Catalog Number 74022217
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Hematoma (1884)
Date of Event 05/23/2013
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient awoke with a large swollen, deformed knee with drainage from surgical site.An irrigation and debridement was performed with an exchange of the tibial baseplate and poly.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached the results of our investigation.(b)(4).
 
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Brand Name
JOURNEY TIBIA BASE NP RT SZ 7
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6793058
Report Number1020279-2017-00627
Device Sequence Number13883966
Product Code JWH
UDI-Device Identifier03596010554390
UDI-Public03596010554390
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K042515
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2013
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/23/2017
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 Date02/08/2021
Device Catalogue Number74022217
Device Lot Number11BM07107
Initial Date Received by Manufacturer 07/18/2017
Supplement Date Received by Manufacturer07/18/2017
Initial Report FDA Received Date08/14/2017
Supplement Report FDA Received Date10/23/2017
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 Hospitalization; Required Intervention;
Patient Age78 YR
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