MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-RM/LL-SZ 3; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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Catalog Number 180613 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
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Patient Problems
Swelling (2091); Injury (2348)
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Event Date 08/18/2017 |
Event Type
Injury
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Manufacturer Narrative
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Review of the product history records indicate the products were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.
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Event Description
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According to the physician, femoral component has sunk in and tilted, implant subsided and wear on plastic.Patient had symptoms started this year.Worsened two months ago associated with swelling.Aspirate excluded infection.She was very well before that.Physician had removed mako implant on (b)(6).Revision done using competitor product.Small size 2.5 f 2.5 t ps 12mm insert.
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Manufacturer Narrative
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An event regarding subsidence involving a mako baseplate was reported.The event reports revision of mako femoral component due to subsidence.Based on the provided information, the product reported in this investigation did not contribute to the event.No alleged deficiencies were reported for this device.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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According to the physician, femoral component has sunk in and tilted, implant subsided and wear on plastic.Patient had symptoms started this year.Worsened two months ago associated with swelling.Aspirate excluded infection.She was very well before that.Physician had removed mako implant on (b)(6).Revision done using competitor product.Small size 2.5 f 2.5 t ps 12mm insert.
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Search Alerts/Recalls
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