|
Catalog Number 209999 |
Device Problem
Computer Software Problem (1112)
|
Patient Problem
Pain (1994)
|
Event Date 01/24/2019 |
Event Type
Injury
|
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.
|
|
Event Description
|
This pi is for the robot used in the primary surgery.Information received from sales rep on (b)(6) 2019: upon review by joint replacement research for surgeon's milestone payment, patients were noted to have had their implant knee removed, revised, or re-operated on as reported in the table attached.Reporter has indicated she does not have access to any additional information as the reporting site takes on all regulatory responsibilities, and all data is de-identified.This pi is for patient 13 of 23, revised due to progression lateral oa, robot used in primary.The patient was revised from pka to tka approximately after 6 years and 2 months of implantation.Pka.
|
|
Event Description
|
This pi is for the robot used in the primary surgery.Information received from sales rep on 1/24/2019: upon review by joint replacement research for surgeon's milestone payment, patients were noted to have had their implant knee removed, revised, or re-operated on as reported in the table attached.Reporter has indicated she does not have access to any additional information as the reporting site takes on all regulatory responsibilities, and all data is de-identified.This pi is for patient 13 of 23, revised due to progression lateral oa, robot used in primary.The patient was revised from pka to tka approximately after 6 years and 2 months of implantation.Pka.
|
|
Manufacturer Narrative
|
An mdr was inadvertently opened for this issue.The patient was revised from a partial to total knee arthroplasty.Based on the information provided, the progression of the patient¿s osteoarthritic condition was the mitigating factor leading to the need for revision and no issues were found with the device during removal.There is no indication that this event is device related.If additional information is received, the reportability decision will be reevaluated.
|
|
Search Alerts/Recalls
|
|
|