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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 11MM; PRSTHSIS, KEE, PTLLOFEMROTIBIL, SMI-CONSTRIND, CMNTD, PLY/MTL/POLYMR
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SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 11MM; PRSTHSIS, KEE, PTLLOFEMROTIBIL, SMI-CONSTRIND, CMNTD, PLY/MTL/POLYMR Back to Search Results
Model Number 74027233
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 03/10/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that revision surgery was performed 20 days after primary due to infection.The journey ii bcs xlpe articular insert sz 3-4 right 11mm was exchanged.
 
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Brand Name
JRNY II BCS XLPE ART ISRT SZ 3-4-RT 11MM
Common Device Name
PRSTHSIS, KEE, PTLLOFEMROTIBIL, SMI-CONSTRIND, CMNTD, PLY/MTL/POLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9926243
Report Number1020279-2020-01146
Device Sequence Number2817687
Product Code JWH
UDI-Device Identifier00885556179116
UDI-Public00885556179116
Combination Product (Y/N)N
Initial Reporter CountryJA
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 12/06/2020
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 Number74027233
Device Catalogue Number74027233
Device Lot Number18FM15468
Initial Date Received by Manufacturer 03/10/2020
Supplement Date Received by Manufacturer12/01/2020
Initial Report FDA Received Date04/05/2020
Supplement Report FDA Received Date12/06/2020
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;
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