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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 1-2 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 1-2 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL Back to Search Results
Catalog Number 71453204
Health Effect - Clinical Code Joint Dislocation (2374)
Date of Event 05/23/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that patient underwent a revision surgery with exchange of poly insert due to insert dislocation.Poly came out of the tray in (b)(6) 2017, surgeon removed loose poly, inspected the locking detail on the tray and performed a poly swap.
 
Additional Manufacturer Narrative
Please review attached for the investigation results.(b)(4).
 
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Brand Name
LGN PS HIGH FLEX XLPE SZ 1-2 15MM
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 Key6653274
Report Number1020279-2017-00446
Device Sequence Number1970644
Product Code JWH
UDI-Device Identifier00885556034989
UDI-Public00885556034989
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
K071071
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/03/2017
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 Catalogue Number71453204
Device Lot Number08JM22049
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2017
Initial Date Received by Manufacturer 05/23/2017
Supplement Date Received by Manufacturer05/23/2017
Initial Report FDA Received Date06/20/2017
Supplement Report FDA Received Date10/03/2017
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;
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