MAKO SURGICAL CORP. UNKNOWN_MAKO PKA; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number UNK_OFL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544)
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Event Date 01/14/2019 |
Event Type
Injury
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Event Description
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Dr.Performed initial medial uka surgery on the patient's right knee and followed up with patient post-operatively.10-year follow-up of the patient occurred on (b)(6) 2022.Information collected on patient reported: patient reported a revision to their medial uka on (b)(6) 2019.Reason for revision was pain, walking limited; patient was revised to a tka.
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Manufacturer Narrative
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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.
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Event Description
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Dr.Performed initial medial uka surgery on the patient's right knee and followed up with patient post-operatively.10-year follow-up of the patient occurred on (b)(6)2022.Information collected on patient reported: patient reported a revision to their medial uka on 14jan2019.Reason for revision was pain, walking limited; patient was revised to a tka.
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Manufacturer Narrative
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Reported event: an event regarding pain involving an unknown mako knee 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: it was reported that the patient was revised due to pain.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.H3 other text : device not returned.
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