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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS TIBIAL BASEPLATE, SIZE 4

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ONKOS SURGICAL ELEOS TIBIAL BASEPLATE, SIZE 4 Back to Search Results
Model Number TB-2204E-01M
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/11/2021
Event Type  malfunction  
Manufacturer Narrative
The root cause for the complaint was unable to be definitively determined. The sales representative reported that there was no poly taper plug present when the packaging of the tibial baseplate. However, the dhr shows that the plug was assigned as a subcomponent and the other part of the lot was pulled from finished goods and the plug was present. There have been no other complaints of the poly taper plug being missing. The poly taper plug is used infrequently as the tibial baseplate is often used with a stem extension. However, prior to the design change to add the screw hole, even if no stem extension or poly taper plug were used, no cement would be able to extrude out through the implant as there was no through hole. Now that there is a screw hole in the implant, it is necessary to utilize the poly taper plug when no stem extension is used. The root cause analysis conducted as part of (b)(4) found the following root causes to the issue: the surgical technique did not provide guidance or emphasize the necessity with the new design to use the taper plug when there is no stem extension. The field did not know the necessity to use the taper plug with the new design.
 
Event Description
A patient was undergoing a surgery on (b)(6) 2021 performed by dr. (b)(6) when the surgeon placed a tibial baseplate without a stem extension. While cementing the tibial baseplate into the patient's tibia, cement started to extrude through the screw hole and out of the top of the implant. The surgeon removed the tibial baseplate intraoperatively and cleaned away the cement. The tibial baseplate is packaged with a taper poly plug which can be optionally used if a stem extension is not being implant. However, the sales representative stated that there was no plug packaged with the implant. The surgeon was able to plug the tibial baseplate with a metal plug and implanted the tibial baseplate successfully. The intraoperative issue led to a delay in surgery of between 10 and 40 minutes.
 
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Brand NameELEOS
Type of DeviceTIBIAL BASEPLATE, SIZE 4
Manufacturer (Section D)
ONKOS SURGICAL
77 east halsey road
parsippany NJ 07054
Manufacturer (Section G)
QUALITY TECH SERVICES
10525 hamshire ave, s
bloomington MN 55438
Manufacturer Contact
jonathan zachok
77 east halsey road
parsippany, NJ 07054
MDR Report Key12442386
MDR Text Key278819228
Report Number3013450937-2021-00195
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K203588
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTB-2204E-01M
Device Catalogue NumberTB-2204E-01M
Device Lot Number90126
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/21/2021
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: 09/08/2021 Patient Sequence Number: 1
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