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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS PAT RESRF RD 35 MM STD; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
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SMITH & NEPHEW, INC. JRNY BCS PAT RESRF RD 35 MM STD; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY Back to Search Results
Model Number 74024835
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code Injury (2348)
Date of Event 03/27/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient suffered from a vertical patellar fracture on the left knee.The event was discovered via x rays which showed the vertical fracture.The event was resolved.
 
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Brand Name
JRNY BCS PAT RESRF RD 35 MM STD
Common Device Name
PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9900940
Report Number1020279-2020-01058
Device Sequence Number14160047
Product Code JWH
UDI-Device Identifier03596010554543
UDI-Public03596010554543
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K042515
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 03/17/2021
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 Model Number74024835
Device Catalogue Number74024835
Device Lot Number16LM08618
Initial Date Received by Manufacturer 03/04/2020
Supplement Date Received by Manufacturer02/18/2021
Initial Report FDA Received Date03/30/2020
Supplement Report FDA Received Date03/17/2021
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 Age77 YR
Patient Weight96
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