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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK FEM ASSEMBLY SZ 5 RT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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SMITH & NEPHEW, INC. LGN HK FEM ASSEMBLY SZ 5 RT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 71421365
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Infiltration into Tissue (1931); Injury (2348)
Event Date 01/01/2020
Event Type  Injury  
Event Description
It was reported that the clinical subject experienced neuropathic pain following the procedure. This condition has consequences for normal daily living and social life. The event was treated via infiltration and its not considered resolved.
 
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Brand NameLGN HK FEM ASSEMBLY SZ 5 RT
Type of DevicePROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10536418
MDR Text Key207014915
Report Number1020279-2020-04578
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71421365
Device Catalogue Number71421365
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/15/2020 Patient Sequence Number: 1
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