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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; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
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SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN LT SZ 7; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED Back to Search Results
Catalog Number 74022127
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Pain (1994)
Date of Event 06/22/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported a revision knee surgery was performed due to pain.The patella was resurfaced during the revision surgery.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.
 
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Brand Name
JRNY BCS II FEMORAL OXIN LT SZ 7
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6732111
Report Number1020279-2017-00548
Device Sequence Number1371323
Product Code JWH
UDI-Device Identifier00885556170519
UDI-Public00885556170519
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K111711
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/10/2017
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 Date03/19/2023
Device Catalogue Number74022127
Device Lot Number13CM13606
Initial Date Received by Manufacturer 06/22/2017
Supplement Date Received by Manufacturer06/22/2017
Initial Report FDA Received Date07/21/2017
Supplement Report FDA Received Date10/10/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
74022226/(B)(4); 74027261/(B)(4)
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age70 YR
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