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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR INS XLPE LAT 5-6 LT 10MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,PLYMR/METAL/PLYMR
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SMITH & NEPHEW, INC. JRNY II XR INS XLPE LAT 5-6 LT 10MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,PLYMR/METAL/PLYMR Back to Search Results
Model Number 74023862
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Injury (2348)
Date of Event 05/09/2018
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that patient presented left knee arthrofibrosis.Adverse event was treated with manipulation under anesthesia.Event was resolved.
 
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Brand Name
JRNY II XR INS XLPE LAT 5-6 LT 10MM
Common Device Name
PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,PLYMR/METAL/PLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key10013909
Report Number1020279-2020-01410
Device Sequence Number2952912
Product Code JWH
UDI-Device Identifier00885556615768
UDI-Public00885556615768
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K152726
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source health professional,study
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 12/11/2020
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 Number74023862
Device Catalogue Number74023862
Device Lot Number16MM10814
Initial Date Received by Manufacturer 04/06/2020
Supplement Date Received by Manufacturer12/09/2020
Initial Report FDA Received Date04/30/2020
Supplement Report FDA Received Date12/11/2020
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;
Patient Weight108
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