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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 5; PRSTHSS,KNEE,PTLLFMRTBL,SMICNSTRND,CMNTD,PLYMRMETALPLYMR
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SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN RT SZ 5; PRSTHSS,KNEE,PTLLFMRTBL,SMICNSTRND,CMNTD,PLYMRMETALPLYMR Back to Search Results
Catalog Number 74022115
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Pain (1994)
Date of Event 11/22/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to anterior knee pain, patella resurfacing was exchanged due to this issue.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.
 
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Brand Name
JRNY BCS II FEMORAL OXIN RT SZ 5
Common Device Name
PRSTHSS,KNEE,PTLLFMRTBL,SMICNSTRND,CMNTD,PLYMRMETALPLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7057210
Report Number1020279-2017-01102
Device Sequence Number126338
Product Code JWH
UDI-Device Identifier00885556169919
UDI-Public00885556169919
Combination Product (Y/N)N
Initial Reporter CountrySF
PMA/510(K) Number
K111711
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 02/19/2018
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 Date01/09/2025
Device Catalogue Number74022115
Device Lot Number15AM07828
Initial Date Received by Manufacturer 11/23/2017
Supplement Date Received by Manufacturer11/23/2017
Initial Report FDA Received Date11/23/2017
Supplement Report FDA Received Date02/19/2018
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 Age76 YR
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