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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 3-4 LT 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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SMITH & NEPHEW, INC. JRNY II XR INS XLPE LAT 3-4 LT 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL Back to Search Results
Model Number 74023841
Medical Device Problem Code Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994)
Date of Event 06/19/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
It was reported that, after tka surgery had been performed on (b)(6) 2017, the patient experienced a patella instability in the left knee.This adverse event was solved by revision surgery on (b)(6) 2018.Patient outcome as been resolved.
 
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Brand Name
JRNY II XR INS XLPE LAT 3-4 LT 9MM
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key12511076
Report Number1020279-2021-07048
Device Sequence Number3908315
Product Code JWH
UDI-Device Identifier00885556615669
UDI-Public00885556615669
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
PMA/510(K) Number
K152726
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional,study
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 11/01/2021
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? Yes
Operator of Device Health Professional
Device Expiration Date06/18/2026
Device Model Number74023841
Device Catalogue Number74023841
Device Lot Number16FM15122
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/31/2021
Supplement Date Received by Manufacturer10/29/2021
Initial Report FDA Received Date09/21/2021
Supplement Report FDA Received Date11/01/2021
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; Other; Required Intervention;
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