MAKO SURGICAL CORP. MCK FEMORAL-RM-LL-SZ 5; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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Model Number 180515 |
Device Problems
Insufficient Information (3190); Migration (4003)
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Patient Problems
Pain (1994); Injury (2348); Joint Dislocation (2374)
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Event Date 06/03/2020 |
Event Type
Injury
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Manufacturer Narrative
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Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
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Event Description
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It was reported that the patient's right mako partial knee was revised due to medial subsidence of the femoral component, subsidence of the tibial component, and extreme poly wear.Surgeon stated the opinion that poly wear/ debris was a cause or contributor for femoral subsidence.Patient was revised to a total knee.Rep provided the original usage report and explant pictures.The devices are allegedly available for return, otherwise the rep confirmed that no further information will be released.
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Manufacturer Narrative
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Reported event an event regarding subsidence involving a mako femoral component was reported.The event was not confirmed.Method & results: product evaluation and results: material evaluation was completed and indicated the following comments: material loss due to articulation was observed on the lateral side of the implant.The xrf analyzes showed that the components were consistent with their respective drawings.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: no medical records were received for review with a clinical consultant.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 has been no other similar events for the lot referenced.Conclusions: material evaluation was indicated the xrf analyzes showed that the components were consistent with their respective drawings.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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It was reported that the patient's right mako partial knee was revised due to medial subsidence of the femoral component, subsidence of the tibial component, and extreme poly wear.Surgeon stated the opinion that poly wear/ debris was a cause or contributor for femoral subsidence.Patient was revised to a total knee.Rep provided the original usage report and explant pictures.The devices are allegedly available for return, otherwise the rep confirmed that no further information will be released.
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Search Alerts/Recalls
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