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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.
 
Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and no relevant clinical medical information was provided to conduct a thorough medical assessment.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.
 
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Brand Name
FEMORAL SIZE D LM/RL
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8480608
MDR Text Key140867997
Report Number1020279-2019-01374
Device Sequence Number1
Product Code HSX
UDI-Device Identifier00885556619896
UDI-Public00885556619896
Combination Product (y/n)N
PMA/PMN Number
K033363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
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
Date Manufacturer Received03/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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