STRYKER ORTHOPAEDICS-MAHWAH MRH TIB ROT COMP XS-XL; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 64812100 |
Device Problem
Material Deformation (2976)
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Patient Problem
Injury (2348)
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Event Date 05/27/2019 |
Event Type
Injury
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Manufacturer Narrative
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An event regarding revision due to fracture of an mrh femoral component involving an mrh tibial component was reported conclusion: a full investigation was completed for the fracture of the femoral component.Based on the information provided there is no indication or allegation that the product reported in this investigation contributed to the event; however, the device was found to be damaged, consistent with impingement with the femoral component.It is noted that in order to explant and replace the axle which joins the femoral and tibial constructs, the knee joint bearing components need to be disassembled and it is good surgical practice that all bearing components are revised as a precautionary measure.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.
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Event Description
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It was reported that a patient underwent a revision surgery due to fracture.The patient had an original implant in 2013, which was revised in (b)(6) 2017.This fractured again in (b)(6) 2019 and this pi is for the operation carried last week.
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Search Alerts/Recalls
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