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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY II CR INSERT XLPE RT SZ 3-4 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
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SMITH & NEPHEW, INC. JOURNEY II CR INSERT XLPE RT SZ 3-4 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED Back to Search Results
Catalog Number 74025633
Medical Device Problem Code Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes Pain (1994); Injury (2348)
Date of Event 03/31/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported a revision surgery was performed due to pain and laxity.
 
Additional Manufacturer Narrative
Please see investigation summary attached.(b)(4).
 
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Brand Name
JOURNEY II CR INSERT XLPE RT SZ 3-4 11MM
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6465241
Report Number1020279-2017-00243
Device Sequence Number476145
Product Code JWH
UDI-Device Identifier00885556422588
UDI-Public00885556422588
Combination Product (Y/N)N
Initial Reporter StateID
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
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 09/29/2017
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 Date01/05/2024
Device Catalogue Number74025633
Device Lot Number14AM04104
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2017
Initial Date Received by Manufacturer 03/31/2017
Supplement Date Received by Manufacturer03/31/2017
Initial Report FDA Received Date04/06/2017
Supplement Report FDA Received Date09/29/2017
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;
Patient Age70 YR
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