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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMITH & NEPHEW IMPACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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SMITH & NEPHEW, INC. SMITH & NEPHEW IMPACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Device Problem Separation Failure (2547)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/16/2018
Event Type  malfunction  
Event Description
During a total knee arthroplasty, during placement of the femoral component, the impactor would not release from the implant.After multiple attempts to get the impactor to release the implant, the dr chose to remove the entire piece, implant and impactor.A second impactor was obtained, as well as a new implant.Procedure was completed.
 
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Brand Name
SMITH & NEPHEW IMPACTOR
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
SMITH & NEPHEW, INC.
MDR Report Key7984442
MDR Text Key124660505
Report NumberMW5080695
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 10/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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