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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II ISRT XLPE DD RT SZ 5-6 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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SMITH & NEPHEW, INC. JRNY II ISRT XLPE DD RT SZ 5-6 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL Back to Search Results
Catalog Number 74025753
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Fever (1858)
Date of Event 03/28/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Customer indicated that there is no product/device to be returned for investigation analysis.
 
Event or Problem Description
After getting scratched on the knee and fever, doctor decided to debride the patient's wound as an extra precaution (to prevent any further possible signs of sepsis).Along with the debridement he exchanged the poly.
 
Additional Manufacturer Narrative
(b)(4).
 
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Brand Name
JRNY II ISRT XLPE DD RT SZ 5-6 11MM
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6498279
Report Number1020279-2017-00268
Device Sequence Number1010010
Product Code JWH
UDI-Device Identifier00885556098110
UDI-Public00885556098110
Combination Product (Y/N)N
Initial Reporter CountrySF
PMA/510(K) Number
K113482
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 08/08/2017
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 Date04/05/2024
Device Catalogue Number74025753
Device Lot Number14DM06613
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/28/2017
Supplement Date Received by Manufacturer03/28/2017
Initial Report FDA Received Date04/17/2017
Supplement Report FDA Received Date08/08/2017
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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