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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 Unintended Movement (3026)
Health Effect - Clinical Code Pain (1994)
Date of Event 01/10/2014
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a left knee revision surgery was performed due to patella mechanical loosening and pain.
 
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 Key6734262
Report Number1020279-2017-00549
Device Sequence Number13795959
Product Code JWH
UDI-Device Identifier03596010554567
UDI-Public03596010554567
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K042515
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2014
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date (Section B) 11/03/2017
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 No Information
Device Expiration Date01/14/2019
Device Catalogue Number74024841
Device Lot Number09AM12855
Initial Date Received by Manufacturer 06/22/2017
Supplement Date Received by Manufacturer06/22/2017
06/22/2017
Initial Report FDA Received Date07/21/2017
Supplement Report FDA Received Date07/28/2017
11/03/2017
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/UNKNOWN; 74022227/UNKNOWN; 74027281/UNKNOWN
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age70 YR
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