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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEMORAL SIZE D LM/RL PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

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SMITH & NEPHEW, INC. FEMORAL SIZE D LM/RL PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number OR00584201401
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Injury (2348)
Event Date 03/15/2019
Event Type  Injury  
Event Description

It was reported that the patient is presenting pain on its left knee. Medical assessment confirms loosening of implants. No procedure has been performed to correct the issue.

 
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Brand NameFEMORAL SIZE D LM/RL
Type of DevicePROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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 Key8480608
MDR Text Key140867997
Report Number1020279-2019-01374
Device Sequence Number1
Product Code HSX
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK033363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/15/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/03/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberOR00584201401
Device LOT Number63408604
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 Received03/15/2019
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: 04/03/2019 Patient Sequence Number: 1
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