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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP RT SZ 7; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
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SMITH & NEPHEW, INC. JRNY II CR FEM OX NP RT SZ 7; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, Back to Search Results
Model Number 74021157
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Loss of Range of Motion (2032)
Date of Event 05/30/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported, after a tka surgery had been performed in which a journey ii cr femoral component was implanted, the clinical subject presented stiffness in the right knee.It cannot be excluded that the adverse event is linked to the surgery.The event was resolved with manipulation under anesthesia.
 
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Brand Name
JRNY II CR FEM OX NP RT SZ 7
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key10043923
Report Number1020279-2020-01574
Device Sequence Number3791990
Product Code JWH
UDI-Device Identifier00885556422823
UDI-Public00885556422823
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
PMA/510(K) Number
K121443
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 12/14/2020
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 Number74021157
Device Catalogue Number74021157
Device Lot Number16MM06182
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/14/2020
Supplement Date Received by Manufacturer12/09/2020
Initial Report FDA Received Date05/11/2020
Supplement Report FDA Received Date12/14/2020
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 Required Intervention;
Patient Age57 YR
Patient Weight103
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