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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE RT SZ 3-4 9MM; PRSTHSIS, KNEE, PATELLOFMOROTBIAL, SMCNSTRAINED, CMNTD, POLYMERMETAL
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SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE RT SZ 3-4 9MM; PRSTHSIS, KNEE, PATELLOFMOROTBIAL, SMCNSTRAINED, CMNTD, POLYMERMETAL Back to Search Results
Catalog Number 74025631
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Information (3190)
Date of Event 11/03/2014
Type of Reportable Event Serious Injury
Event or Problem Description
A journey cr right 9mm insert was exchanged for a journey right cr 15 mm deep dished insert for more stabilization.The pcl was also compromised.
 
Additional Manufacturer Narrative
Please review attached for investigation results.(b)(4).
 
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Brand Name
JRNY II CR ISRT XLPE RT SZ 3-4 9MM
Common Device Name
PRSTHSIS, KNEE, PATELLOFMOROTBIAL, SMCNSTRAINED, CMNTD, POLYMERMETAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7073523
Report Number1020279-2017-01171
Device Sequence Number16174610
Product Code JWH
UDI-Device Identifier00885556422601
UDI-Public00885556422601
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K121443
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2017
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 02/22/2018
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 No Information
Device Catalogue Number74025631
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/28/2017
Supplement Date Received by Manufacturer11/28/2017
Initial Report FDA Received Date11/30/2017
Supplement Report FDA Received Date02/22/2018
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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