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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN LT SZ 7; PROSTHSIS,KNEE,PATELLOFEMOROTIBIAL,SMI-CONSTRAIND,CMNTD,POLYMR/MTAL/POLYMER
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SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN LT SZ 7; PROSTHSIS,KNEE,PATELLOFEMOROTIBIAL,SMI-CONSTRAIND,CMNTD,POLYMR/MTAL/POLYMER Back to Search Results
Catalog Number 74022127
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 09/29/2015
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient underwent an irrigation and a debridement with polyethylene exchange in the left knee due to left knee arthrofibrosis and infection.The tibial insert component was removed.
 
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Brand Name
JRNY BCS II FEMORAL OXIN LT SZ 7
Common Device Name
PROSTHSIS,KNEE,PATELLOFEMOROTIBIAL,SMI-CONSTRAIND,CMNTD,POLYMR/MTAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7016341
Report Number1020279-2017-00994
Device Sequence Number16172552
Product Code JWH
UDI-Device Identifier00885556170519
UDI-Public00885556170519
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K111711
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date (Section B) 02/10/2018
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 Date09/05/2024
Device Catalogue Number74022127
Device Lot Number14JM05176
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/30/2017
Supplement Date Received by Manufacturer10/30/2017
10/30/2017
Initial Report FDA Received Date11/09/2017
Supplement Report FDA Received Date11/10/2017
02/10/2018
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 Hospitalization; Required Intervention;
Patient Age69 YR
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