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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN RT SZ 6; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
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SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN RT SZ 6; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED Back to Search Results
Catalog Number 74022116
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Post Operative Wound Infection (2446)
Date of Event 03/15/2013
Type of Reportable Event Serious Injury
Event or Problem Description
The patient presented with a right knee wound.The patient underwent a debridement of skin and tendon.
 
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Please see attached file for our results of investigation.(b)(4).
 
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Brand Name
JRNY BCS II FEMORAL OXIN RT SZ 6
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6822162
Report Number1020279-2017-00661
Device Sequence Number60430
Product Code JWH
UDI-Device Identifier00885556169964
UDI-Public00885556169964
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K111711
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 11/02/2017
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 Date01/28/2022
Device Catalogue Number74022116
Device Lot Number12AM18833
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/10/2017
Supplement Date Received by Manufacturer08/10/2017
Initial Report FDA Received Date08/25/2017
Supplement Report FDA Received Date11/02/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 Yes
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
74022214/12CM06111; 74024626/08FM03009; 74027232/12CM00489
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age76 YR
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