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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 7-8 LT 9MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL
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SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 7-8 LT 9MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL Back to Search Results
Catalog Number 74027281
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 12/22/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a revision surgery of the insert was performed due to knee contracture.There is no damage but adhesion of the soft tissue on the insert.The surgeon decided it is not the product failure.
 
Additional Manufacturer Narrative
Add'l info: the associated complaint device was not returned for evaluation.Please see attached file for our results of investigation.
 
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Brand Name
JRNY II BCS XLPE ART ISRT SZ 7-8 LT 9MM
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 Key7155324
Report Number1020279-2017-01365
Device Sequence Number1979398
Product Code JWH
UDI-Device Identifier00885556178317
UDI-Public00885556178317
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K111711
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 03/01/2018
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 Catalogue Number74027281
Device Lot Number15LM11806
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/25/2017
Supplement Date Received by Manufacturer12/25/2017
Initial Report FDA Received Date12/29/2017
Supplement Report FDA Received Date03/02/2018
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 Required Intervention;
Patient Age40 YR
Patient Weight100
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