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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY UNI TIBIAL BASE LM/RL SZ 3; PRSTHSS,KNEE,FMRTBIL,NONCNSTRND,CMNTD,MTAL/PLYMR
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SMITH & NEPHEW, INC. JRNY UNI TIBIAL BASE LM/RL SZ 3; PRSTHSS,KNEE,FMRTBIL,NONCNSTRND,CMNTD,MTAL/PLYMR Back to Search Results
Catalog Number 71422423
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Injury (2348)
Date of Event 11/28/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed to remove journey uni knee prosthesis.Surgeon does not fault the device.
 
Additional Manufacturer Narrative
Please see the attached file for the results of our investigation.(b)(4).
 
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Brand Name
JRNY UNI TIBIAL BASE LM/RL SZ 3
Common Device Name
PRSTHSS,KNEE,FMRTBIL,NONCNSTRND,CMNTD,MTAL/PLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7065032
Report Number1020279-2017-01133
Device Sequence Number13482351
Product Code HSX
UDI-Device Identifier03596010582058
UDI-Public03596010582058
Combination Product (Y/N)N
Initial Reporter CountrySF
PMA/510(K) Number
K102069
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 03/09/2018
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 Health Professional
Device Expiration Date06/09/2024
Device Catalogue Number71422423
Device Lot Number14FM08955
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 11/28/2017
Supplement Date Received by Manufacturer11/28/2017
Initial Report FDA Received Date11/28/2017
Supplement Report FDA Received Date03/09/2018
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 Age52 YR
Patient Weight65
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