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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HINGE DIS FEM WDG TRL SZ 3 5MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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SMITH & NEPHEW, INC. LEGION HINGE DIS FEM WDG TRL SZ 3 5MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 71434229
Device Problem Break (1069)
Patient Problem Injury (2348)
Event Date 12/05/2018
Event Type  Injury  
Event Description
It was reported that revision surgery was performed due to the wedge being broken.No delay reported.
 
Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, no clinically relevant supporting documentation was provided, therefore, a thorough medical investigation could not be performed.However, the reported broken wedge was likely the contributing factor to the reported revision.The patient impact beyond the reported revision and expected post-surgical rehab cannot be determined.No further medical assessment is warranted at this time.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.
 
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Brand Name
LEGION HINGE DIS FEM WDG TRL SZ 3 5MM
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8213248
MDR Text Key131946969
Report Number1020279-2019-00026
Device Sequence Number1
Product Code HRY
UDI-Device Identifier00885556032169
UDI-Public00885556032169
Combination Product (y/n)N
PMA/PMN Number
K121393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number71434229
Date Manufacturer Received12/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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