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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 4; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMER/METL/POLYMR
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SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN LT SZ 4; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMER/METL/POLYMR Back to Search Results
Catalog Number 74022124
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/28/2017
Type of Reportable Event Serious Injury
Event or Problem Description
Patient presented post-operatory pain.Subject had 10 ml fluid aspirated and received a dexamethasone injection.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached for the results of our investigation.
 
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Brand Name
JRNY BCS II FEMORAL OXIN LT SZ 4
Common Device Name
PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMER/METL/POLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7143309
Report Number1020279-2017-01333
Device Sequence Number19142028
Product Code JWH
UDI-Device Identifier00885556170366
UDI-Public00885556170366
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
Report Date (Section B) 02/18/2018
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 Date11/30/2024
Device Catalogue Number74022124
Device Lot Number14MM03269
Initial Date Received by Manufacturer 12/06/2017
Supplement Date Received by Manufacturer12/06/2017
Initial Report FDA Received Date12/22/2017
Supplement Report FDA Received Date02/18/2018
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;
Patient Age77 YR
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