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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.
 
Manufacturer Narrative
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.The knee was assessed as stable at completion of revision operation.
 
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Brand Name
PROFIX {} C/R HA POR FEM SZ 5 LT
Type of Device
PRSTHSS,KNEE,PATELLO/FMOROTBIAL,SMI-CNSTRND,UNCMNTD,POROUS,COTED,PLYMR/MTL/PLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9881262
MDR Text Key185932983
Report Number1020279-2020-01017
Device Sequence Number1
Product Code MBH
UDI-Device Identifier03596010484710
UDI-Public03596010484710
Combination Product (y/n)N
PMA/PMN Number
K030623
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
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
Date Manufacturer Received06/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age72 YR
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