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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNEE INSTRUMENT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
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SMITH & NEPHEW, INC. KNEE INSTRUMENT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY Back to Search Results
Device Problems Break (1069); Device Fell (4014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/25/2019
Event Type  malfunction  
Event Description
It was reported that a trial was lost during a case and was wondering if there is something inside of the trial that can be picked up by x-ray or if it is a possibility to have something added during manufacturing that could allow this.As part of a patient care review, she would like an answer so she can complete her report of this incident.
 
Event Description
It was reported that a trial was lost during a case and was wondering if there is something inside of the trial that can be picked up by x-ray or if it is a possibility to have something added during manufacturing that could allow this.
 
Manufacturer Narrative
The associated complaint device was not returned.The part and batch number was not provided.In general, if the trial is a patella, tibia articular insert, or tibia spacer there is no radiological marker in the trial that can be seen on an x-ray.Femoral, offset coupler, and stem trials are visible in an x-ray.A request for this type of device may be possible with a project in inventures, where some devices can be customized to the surgeons needs.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
 
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Brand Name
KNEE INSTRUMENT
Type of Device
PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8435063
MDR Text Key139293914
Report Number1020279-2019-01117
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 07/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Initial Date Manufacturer Received 02/25/2019
Initial Date FDA Received03/19/2019
Supplement Dates Manufacturer Received02/25/2019
Supplement Dates FDA Received07/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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