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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS PAT RESRF RD 41 MM STD; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
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SMITH & NEPHEW, INC. JRNY BCS PAT RESRF RD 41 MM STD; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED Back to Search Results
Catalog Number 74024841
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Inflammation (1932); Pain (1994)
Date of Event 03/15/2013
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported the patient presented with left knee synovitis and pain and was administered prednisone.
 
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 PAT RESRF RD 41 MM STD
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6773027
Report Number1020279-2017-00600
Device Sequence Number16276462
Product Code JWH
UDI-Device Identifier03596010554567
UDI-Public03596010554567
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K111711
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/17/2017
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 Date01/14/2019
Device Catalogue Number74024841
Device Lot Number09AM12855
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/31/2017
Supplement Date Received by Manufacturer07/31/2017
Initial Report FDA Received Date08/08/2017
Supplement Report FDA Received Date10/17/2017
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
74022128/(B)(4); 74022227/(B)(4); 74027281/(B)(4)
Outcome Attributed to Adverse Event Required Intervention;
Patient Age69 YR
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