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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION POROUS HA TIBIAL BASE SZ 4 LT PROST, KNEE, PATE/FEMOR, SEMI-CONS, UNCE, PORO, COAT, POLY/METAL/POLY

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SMITH & NEPHEW, INC. LEGION POROUS HA TIBIAL BASE SZ 4 LT PROST, KNEE, PATE/FEMOR, SEMI-CONS, UNCE, PORO, COAT, POLY/METAL/POLY Back to Search Results
Model Number 71934056
Device Problem Unintended Movement (3026)
Patient Problem Injury (2348)
Event Date 04/21/2015
Event Type  Injury  
Event Description

It was reported that the patient presented aseptic loosening on the tibial baseplate of the left knee. This was noticed when the radiographic images showed radiolucencies on that component. It is unknown how the complication was treated.

 
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Brand NameLEGION POROUS HA TIBIAL BASE SZ 4 LT
Type of DevicePROST, KNEE, PATE/FEMOR, SEMI-CONS, UNCE, PORO, COAT, POLY/METAL/POLY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key9814225
MDR Text Key182944342
Report Number1020279-2020-00826
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK100897
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type STUDY
Reporter Occupation
Type of Report Initial
Report Date 03/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/10/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number71934056
Device Catalogue Number71934056
Device LOT Number14BM07212A
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/26/2014
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: 03/10/2020 Patient Sequence Number: 1
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