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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 7-8 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
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SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 7-8 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, Back to Search Results
Model Number 71453233
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Injury (2348)
Date of Event 04/15/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that, after a tka surgery had been performed, the post of a size 7-8 13 mm legion ps high flex xlpe insert broke.The event was resolved by performing a revision surgery to exchange such insert.The patient outcome is unknown.
 
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Brand Name
LGN PS HIGH FLEX XLPE SZ 7-8 13MM
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key10048054
Report Number1020279-2020-01608
Device Sequence Number16983706
Product Code JWH
UDI-Device Identifier00885556033524
UDI-Public00885556033524
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
PMA/510(K) Number
K071071
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 12/10/2020
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? Yes
Operator of Device Health Professional
Device Model Number71453233
Device Catalogue Number71453233
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/15/2020
Supplement Date Received by Manufacturer12/08/2020
Initial Report FDA Received Date05/12/2020
Supplement Report FDA Received Date12/10/2020
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 Age64 YR
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