Model Number 209999 |
Device Problem
Insufficient Information (3190)
|
Patient Problems
Unspecified Infection (1930); Injury (2348)
|
Event Date 03/09/2020 |
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
|
It was reported that the patient's right knee was revised due to infection.A 6x9 cs insert was revised for another 6x9 cs insert.
|
|
Manufacturer Narrative
|
Reported event: it was reported ¿it was reported that the patient's right knee was revised due to infection.A 6x9 cs insert was revised for another 6x9 cs insert.¿ product evaluation and results: review of the case session files was not performed as case session data was not provided.Product history review: review of the device history records associated with (b)(6) indicate that on 25/05/2015 quality inspection procedures were completed with no reported discrepancies.Complaint history review: a search of the complaint database under device identification pn 209999 reports no similar complaints for tka software - other.Conclusions: the failure could not be determined as no case session data or logs were provided after three communication attempts were made.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
|
|
Event Description
|
It was reported that the patient's right knee was revised due to infection.A 6x9 cs insert was revised for another 6x9 cs insert.
|
|
Search Alerts/Recalls
|