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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS PAT RESRF RD 26 MM STD; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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SMITH & NEPHEW, INC. JRNY BCS PAT RESRF RD 26 MM STD; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL Back to Search Results
Catalog Number 74024826
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Failure of Implant (1924); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event 04/12/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that patient underwent a revision surgery as patella was not tracking well.Patient was revised to a 29mm oval patella.
 
Additional Manufacturer Narrative
(b)(4).
 
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Brand Name
JRNY BCS PAT RESRF RD 26 MM STD
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6553716
Report Number1020279-2017-00325
Device Sequence Number11011608
Product Code JWH
UDI-Device Identifier03596010554512
UDI-Public03596010554512
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K042515
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 09/21/2017
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 Catalogue Number74024826
Initial Date Received by Manufacturer 04/12/2017
Supplement Date Received by Manufacturer04/12/2017
Initial Report FDA Received Date05/09/2017
Supplement Report FDA Received Date09/21/2017
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;
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