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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN LT SZ 8; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR
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SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN LT SZ 8; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR Back to Search Results
Catalog Number 74022128
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Injury (2348)
Date of Event 03/16/2016
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported a patient lost range of motion due to arthrofibrosis after tka and undergo manipulation under anesthesia to regain rom.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached file for our results of investigation.(b)(4).
 
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Brand Name
JRNY BCS II FEMORAL OXIN LT SZ 8
Common Device Name
PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7042440
Report Number1020279-2017-01055
Device Sequence Number19109659
Product Code JWH
UDI-Device Identifier00885556170564
UDI-Public00885556170564
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K111711
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 02/22/2018
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 Date10/31/2025
Device Catalogue Number74022128
Device Lot Number15LM01908
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/10/2017
Supplement Date Received by Manufacturer11/10/2017
Initial Report FDA Received Date11/17/2017
Supplement Report FDA Received Date02/23/2018
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 Other; Required Intervention;
Patient Age65 YR
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