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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN RT SZ 7; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
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SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN RT SZ 7; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED Back to Search Results
Catalog Number 74022117
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Pain (1994); Loss of Range of Motion (2032); Swelling (2091)
Date of Event 03/04/2015
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported the patient underwent a manipulation under anesthesia due to flexion contracture.It was also reported the patient had fallen down stairs and had swelling and pain.
 
Additional Manufacturer Narrative
Remaning components of the tka involved in this event have been communicated through mdrs 1020279-2017-01145, (b)(4) and 1020279-2017-01148.[(b)(4)].
 
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Brand Name
JRNY BCS II FEMORAL OXIN RT SZ 7
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7069952
Report Number1020279-2017-01146
Device Sequence Number1186383
Product Code JWH
UDI-Device Identifier00885556170014
UDI-Public00885556170014
Combination Product (Y/N)N
Initial Reporter CountryNL
PMA/510(K) Number
K111711
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 03/16/2018
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 Date05/13/2024
Device Catalogue Number74022117
Device Lot Number14EM13259
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/30/2017
Supplement Date Received by Manufacturer10/30/2017
Initial Report FDA Received Date11/30/2017
Supplement Report FDA Received Date03/16/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
71420568/14FM16366; 74022217/14AM24902; 74027271/12GM14465
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age65 YR
Patient Weight76
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