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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR INS XLPE MED 3-4 RT 10MM; PROST, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY
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SMITH & NEPHEW, INC. JRNY II XR INS XLPE MED 3-4 RT 10MM; PROST, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY Back to Search Results
Model Number 74023732
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Injury (2348)
Date of Event 02/09/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the clinical subject presented postoperative right knee stiffness.The event was treated via manipulation under anesthesia.
 
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Brand Name
JRNY II XR INS XLPE MED 3-4 RT 10MM
Common Device Name
PROST, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key10015758
Report Number1020279-2020-01430
Device Sequence Number16753300
Product Code JWH
UDI-Device Identifier00885556613085
UDI-Public00885556613085
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K152726
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,study,use
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date (Section B) 12/10/2020
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 Expiration Date11/27/2025
Device Model Number74023732
Device Catalogue Number74023732
Device Lot Number15LM19467
Initial Date Received by Manufacturer 04/08/2020
Supplement Date Received by Manufacturer04/08/2020
04/08/2020
Initial Report FDA Received Date04/30/2020
Supplement Report FDA Received Date12/10/2020
12/10/2020
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 Hospitalization; Required Intervention;
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