STRYKER ORTHOPAEDICS-MAHWAH MRH KNEE FEM XS RHT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 64811101 |
Device Problems
Break (1069); Fracture (1260)
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Patient Problem
Injury (2348)
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Event Date 08/08/2018 |
Event Type
Injury
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Manufacturer Narrative
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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.Device not available.
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Event Description
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It was reported that broken implant inside the patient, revision of the implant is needed which was done on (b)(6) 2018.This implant was implanted for more than 10 years.
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Event Description
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It was reported that broken implant inside the patient, revision of the implant is needed which was done on (b)(6) 2018.This implant was implanted for more than 10 years.
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Manufacturer Narrative
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An event regarding a crack fracture involving an mrh femoral component was reported.The event was confirmed.Wear was also confirmed.Method & results: device evaluation and results: visual inspection: a visual inspection of the returned device was performed by a material analysis engineer which noted; the femoral component fractured at the lateral condyle.The parts were examined with the aid of a stereo microscope at magnifications up to 50x.This damage is consistent with contact against the rotating component.This damage is consistent with articulation against a hard object.The fracture surfaces associated with the femoral component and fractured condyle are noted.Post-fracture abrasion was observed on the fracture surfaces, obscuring regions of the fracture surface.The fracture propagated approximately from the articulating surface to the proximal surface of the condyle.Dimensional inspection: not performed as the device was fractured.Functional inspection: not performed as the device was fractured.Material analysis: a material analysis concluded; the femoral component fractured at the lateral condyle, with the fracture occurring in fatigue.Damage was observed on the femoral component and rotating component, consistent with contact against each other after the condyle fractured.Delamination, burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.Yellow discoloration was also observed on insert, consistent with absorption of synovial fluid.Debris was also observed on the insert.Eds showed the femoral condyle and debris were consistent with astm f75 alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: end of practical service life condition with wear and/or fracture of a poly bumper has contributed to an overload condition in the mrh bearing with hard/hard metal contact between femoral and tibial devices causing fatigue accumulation in the local structures ending in a lateral mrh flange fracture requiring revision after more than 10-years of implantation.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the investigation concluded that the crack/fracture was the result of end of practical service life condition with wear and/or fracture of a poly bumper has contributed to an overload condition in the mrh bearing with hard/hard metal contact between femoral and tibial devices causing fatigue accumulation in the local structures ending in a lateral mrh flange fracture requiring revision after more than 10-years of implantation.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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Search Alerts/Recalls
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