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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL TIBIAL IMPACTOR TIP; KNEE ARTHROPLASTY IMPLANTATION SYSTEM
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CONFORMIS, INC. ITOTAL TIBIAL IMPACTOR TIP; KNEE ARTHROPLASTY IMPLANTATION SYSTEM Back to Search Results
Model Number ED-08155
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/15/2020
Event Type  malfunction  
Manufacturer Narrative
It was reported that the black impactor tip for an itotal identity cr knee broke in half during use on the tibial tray.The surgeon utilized the femoral impactor tip to impact the tibia baseplate upon cementing.This issue did not cause any delays in surgery and the procedure was completed successfully.Neither the serial number nor the patient information was available to conformis with this incident.
 
Event Description
It was reported that the black impactor tip for an itotal identity cr knee broke in half during use on the tibial tray.The surgeon utilized the femoral impactor tip to impact the tibia baseplate upon cementing.This issue did not cause any delays in surgery and the procedure was completed successfully.
 
Event Description
It was reported that the black impactor tip for an itotal identity cr knee broke in half during use on the tibial tray.The surgeon utilized the femoral impactor tip to impact the tibia baseplate upon cementing.This issue did not cause any delays in surgery and the procedure was completed successfully.
 
Manufacturer Narrative
It was reported that the black impactor tip for an itotal identity cr knee broke in half during use on the tibial tray.The surgeon utilized the femoral impactor tip to impact the tibia baseplate upon cementing.This issue did not cause any delays in surgery and the procedure was completed successfully.The broken part was returned for an engineering review.After further investigation, it appears that the tibial impactor tip had been previously misused for quite some time, this is most likely what caused the failure.The impactor tip had visible damage marks on both sides of the mating interface.This area of the part should not be contacted or impacted during the procedure.It appears that instead of pulling the impactor tip off of the adapter that it mates with, a mallet or an equivalent blunt object was used to forcibly remove it.The device is not intended to be used in this manner and most likely, the forceful blows on the sides of the impactor tip, weakened the part causing it to break when being used to impact the tibial tray.
 
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Brand Name
ITOTAL TIBIAL IMPACTOR TIP
Type of Device
KNEE ARTHROPLASTY IMPLANTATION SYSTEM
Manufacturer (Section D)
CONFORMIS, INC.
600 technology park drive
billerica MA 01821
MDR Report Key10638914
MDR Text Key210168710
Report Number3004153240-2020-00179
Device Sequence Number1
Product Code OOG
Combination Product (y/n)N
PMA/PMN Number
K170226
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberED-08155
Device Lot NumberLOT C200401
Was Device Available for Evaluation? No
Date Manufacturer Received10/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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