MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 7-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
|
Back to Search Results |
|
Model Number 180707-1 |
Device Problem
Device Difficult to Setup or Prepare (1487)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/14/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.Device not returned.
|
|
Event Description
|
During a medial partial knee mako procedure perform by (b)(6) (the surgeon), he could not get the polyethylene insert to lock in the tibial baseplate posteriorly.The trial baseplate and trial poly was able to fit with little difficulty during the trialing stage, however the final implant poly would not lock in to the final baseplate mechanism despite the surgeons efforts.Four different polyethylene inserts where used with the same outcome.Ultimately the surgeon made the decision to complete the case without achieving complete locking of the insert posteriorly - it achieved locking anteriorly on each occasion.1h delay.Update: tourniquet was continued to be used during the delay but was turned off at a tourniquet time of two hours.
|
|
Search Alerts/Recalls
|
|
|