MAKO SURGICAL CORP. MCK PATELLOFEMORAL-L-SZ 6; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
|
Back to Search Results |
|
Model Number 180406 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
|
Patient Problem
Pain (1994)
|
Event Date 11/12/2021 |
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.Device not returned.
|
|
Event Description
|
Dr.Revised a left mako uni patellofemoral to a primary total knee due to pain.Original surgery was (b)(6) 2013.It was a size 6 mako mck patellofemoral and the original patella used was a competitor.
|
|
Manufacturer Narrative
|
Reported event: an event regarding pain involving a mako femoral component was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional, and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.H3 other text : device not returned.
|
|
Event Description
|
Dr.Revised a left mako uni patellofemoral to a primary total knee due to pain.Original surgery was (b)(6) 2013.It was a size 6 mako mck patellofemoral and the original patella used was a competitor.
|
|
Search Alerts/Recalls
|
|
|