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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN KNEE IMPLANT PROSTHSIS, HP,SMI-CONSTRIND,MTL/CRMIC/POLYMR,CMNTDORNON-PROUS, UNCMNTD

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SMITH & NEPHEW, INC. UNKNOWN KNEE IMPLANT PROSTHSIS, HP,SMI-CONSTRIND,MTL/CRMIC/POLYMR,CMNTDORNON-PROUS, UNCMNTD Back to Search Results
Model Number 71420154
Device Problem Loss of Osseointegration
Event Date 08/23/2017
Event Type  Injury  
Event Description

It was reported that after primary tkr patient suffered severe pain, discomfort and increasing right knee deformity, which required a revision surgery where patient was found to have loose tibial component with extensive bone loss and femoral component was also loose.

 
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Brand NameUNKNOWN KNEE IMPLANT
Type of DevicePROSTHSIS, HP,SMI-CONSTRIND,MTL/CRMIC/POLYMR,CMNTDORNON-PROUS, UNCMNTD
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN
Manufacturer Contact
sarah freestone
1450 brooks road
memphis , TN 
MDR Report Key9433737
Report Number1020279-2019-04325
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/06/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number71420154
Device Catalogue Number71420154
Device LOT Number10CM11699A
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 12/06/2019 Patient Sequence Number: 1
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