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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 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
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SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN LT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED Back to Search Results
Catalog Number 74022125
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Swelling (2091); Injury (2348)
Date of Event 05/13/2013
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that patient was hospitalized due to left knee swelling, was positive for dvt and was treated with antibiotics.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please review attached for investigation results.(b)(4).
 
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Brand Name
JRNY BCS II FEMORAL OXIN LT SZ 5
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6928156
Report Number1020279-2017-00839
Device Sequence Number99418
Product Code JWH
UDI-Device Identifier00885556170410
UDI-Public00885556170410
Combination Product (Y/N)N
Initial Reporter StateWV
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) 12/06/2017
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 Date01/19/2023
Device Catalogue Number74022125
Device Lot Number13AM06755
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/12/2017
Supplement Date Received by Manufacturer09/12/2017
Initial Report FDA Received Date10/09/2017
Supplement Report FDA Received Date12/06/2017
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 Age73 YR
Patient Weight79
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