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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 10MM SHORT TRIAL RIGHT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. 10MM SHORT TRIAL RIGHT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 71687012
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem Injury (2348)
Event Date 02/24/2016
Event Type  Injury  
Event Description
It was reported that in (b)(6) 2015 patient underwent a stryker thr procedure, due to recurrent effusions without any resolutions, despite aspirations and injections a revision surgery had to be performed in (b)(6) 2016. During that procedure, dr. Decided to use an undersized femoral trial which was inserted into the knee. The trial itself contained a clear directive printed on itself to no insert into the body. The trial had been forcibly pushed in the femur, requiring lytes and suction to remove it. Device did not have a proper locking mechanisms, instead using a pop-on, pop-off mechanism on the trial that resulted in a piece of trial being left behind. Because of this incident, patient continued to have pain and swelling. A third procedure had to be performed in order to take the piece out of the trial of the patients body.
 
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Brand Name10MM SHORT TRIAL RIGHT
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key10126862
MDR Text Key194301306
Report Number1020279-2020-02089
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71687012
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2021
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: 06/08/2020 Patient Sequence Number: 1
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