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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS PAT BICONVEX 26 MM STD; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETAL
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SMITH & NEPHEW, INC. JRNY BCS PAT BICONVEX 26 MM STD; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETAL Back to Search Results
Catalog Number 74024626
Medical Device Problem Codes Loss of or Failure to Bond (1068); Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994)
Date of Event 09/01/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that nearly a year after the tka a revision surgery was performed due to the patient had discomfort and pain while walking.After checking, it appears that the patella implant was dislocated outside its site.The unsealing came from the patella implant and the cement.
 
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Brand Name
JRNY BCS PAT BICONVEX 26 MM STD
Common Device Name
PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6921367
Report Number1020279-2017-00830
Device Sequence Number705556
Product Code JWH
UDI-Device Identifier03596010554475
UDI-Public03596010554475
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K042515
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 02/27/2018
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 Date12/27/2025
Device Catalogue Number74024626
Device Lot Number15MM18815
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/13/2017
Supplement Date Received by Manufacturer09/13/2017
Initial Report FDA Received Date10/06/2017
Supplement Report FDA Received Date02/27/2018
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 Hospitalization; Required Intervention;
Patient Age73 YR
Patient Weight96
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