MAKO SURGICAL CORP. MCK FEMORAL-RM-LL-SZ 2; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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Catalog Number 180512 |
Device Problem
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.
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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 12 mm insert.
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Search Alerts/Recalls
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