MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-LM/RL-SZ 5; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
|
Back to Search Results |
|
Catalog Number 180605 |
Device Problem
Loss of Osseointegration (2408)
|
Patient Problems
Discomfort (2330); Injury (2348); Inadequate Osseointegration (2646)
|
Event Date 09/19/2013 |
Event Type
Injury
|
Manufacturer Narrative
|
An evaluation of the device cannot be performed as the device was retained by the hospital and was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
|
|
Event Description
|
Tibial loosening with mechanical failure, left uka.Revision of tibial compartment.
|
|
Manufacturer Narrative
|
An event regarding loosening involving a mako baseplate was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.-medical records received and evaluation: the provided medical information was submitted to a consulting clinician who indicated: "there are no x-rays available for review, no examination of the explanted components, no confirmation of a loose primary tibial component, and no follow-up status-post revision with a different uka femoral component subsequent to (b)(6) 2013.There is no indication that factors of implant component design, manufacturing or materials were responsible for this clinical situation." -device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.Provided medical records were submitted to a consulting clinician who indicated that no confirmation of a loose primary tibial component and there is no indication that factors of implant component design, manufacturing or materials were responsible for this clinical situation.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
|
|
Event Description
|
Tibial loosening with mechanical failure, left uka.Revision of tibial compartment.
|
|
Search Alerts/Recalls
|
|
|