MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-LM/RL-SZ 5; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
|
Back to Search Results |
|
Model Number 180605 |
Device Problem
Insufficient Information (3190)
|
Patient Problem
Pain (1994)
|
Event Date 02/06/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
An event regarding pain involving a mako baseplate 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 remained implanted.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as primary operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components 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.
|
|
Event Description
|
This pi is for the implants for patient 1 of 3.(b)(6) yo male, surgery (b)(6) 2019.As reported by surgeon: attached are xrays of three patients i previously discussed.All have concerning radiolucencies underneath the tibial baseplate that appeared several months post op.Thus far, none have required revision but all have some degree of pain (mostly medial).Again i never saw this prior the mics transition.Let me know your thoughts and if any other surgeons have seen this issue.More recently, i have been using a 2mm drill to perforate the sclerotic tibial surface to promote better cement interdigitation and my results seem to be much better.Case type: pka 3.0.
|
|
Event Description
|
This pi is for the implants for patient 1 of 3.72 yo male, surgery (b)(6) 2019.As reported by surgeon: attached are xrays of three patients i previously discussed.All have concerning radiolucencies underneath the tibial baseplate that appeared several months post op.Thus far, none have required revision but all have some degree of pain (mostly medial).Again i never saw this prior the mics transition.Let me know your thoughts and if any other surgeons have seen this issue.More recently, i have been using a 2mm drill to perforate the sclerotic tibial surface to promote better cement interdigitation and my results seem to be much better.Case type: (b)(4).
|
|
Manufacturer Narrative
|
Reported event: an event regarding pain involving a mako baseplate 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 remained implanted.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as primary operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components 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.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product nonconformity or unanticipated hazard.H3 other text : device not returned.
|
|
Search Alerts/Recalls
|
|
|