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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PROFIX {} C/R HA POR FEM SZ 5 LT PRSTHSS,KNEE,PATELLO/FMOROTBIAL,SMI-CNSTRND,UNCMNTD,POROUS,COTED,PLYMR/MTL/PLYMR

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SMITH & NEPHEW, INC. PROFIX {} C/R HA POR FEM SZ 5 LT PRSTHSS,KNEE,PATELLO/FMOROTBIAL,SMI-CNSTRND,UNCMNTD,POROUS,COTED,PLYMR/MTL/PLYMR Back to Search Results
Model Number 71503250
Device Problem Unintended Movement (3026)
Patient Problems Pain (1994); Joint Disorder (2373)
Event Date 03/05/2020
Event Type  Injury  
Event Description

It was reported that the patient underwent revision total knee replacement surgery for an unstable knee and continuing increase of pain over a number of years. The original knee surgery was performed in (b)(6) 2005. It was reported that the femur had loosened and that the bone quality was quite poor.

 
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Brand NamePROFIX {} C/R HA POR FEM SZ 5 LT
Type of DevicePRSTHSS,KNEE,PATELLO/FMOROTBIAL,SMI-CNSTRND,UNCMNTD,POROUS,COTED,PLYMR/MTL/PLYMR
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
MDR Report Key9881262
MDR Text Key185932983
Report Number1020279-2020-01017
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK030623
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/25/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/07/2014
Device MODEL Number71503250
Device Catalogue Number71503250
Device LOT Number04GM17371B
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/07/2004
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: 03/25/2020 Patient Sequence Number: 1
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