STRYKER ORTHOPAEDICS-MAHWAH MRH KNEE FEM S RGT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 6481-1-111 |
Device Problem
Fracture (1260)
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Patient Problems
Injury (2348); Ambulation Difficulties (2544)
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Event Date 08/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.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.Device not returned.
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Event Description
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Fractured right mrh femur component.The initial surgery took place on (b)(6) 2007.It has already been revised on (b)(6) 2011 and (b)(6) 2015.Now the third revision will be performed.
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Event Description
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Fractured right mrh femur component.The initial surgery took place on (b)(6) 2007.It has already been revised on (b)(6) 2011 and (b)(6) 2015.Now the third revision will be performed.
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Manufacturer Narrative
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An event regarding crack/fracture involving a mrh femoral component was reported.The event of crack/fracture was confirmed through clinician review of the provided medical records.Method & results: -device evaluation and results: not performed as product was not returned.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: resorption of a local bone graft at the interface of lateral femoral condylar mrh flange and local femoral bone has resulted in loss of bone support with fatigue accumulation in the lateral mrh and ultimately a femoral mrh device fracture at exactly the location of peak overload requiring a third revision with quite likely a femoral gmrs device and cone augment.No details or results of this third revision procedure are known at this time.Does the review identify any procedural related factors that contributed to the event? - resorption of bone graft at the interface of lateral femoral condylar mrh flange contributing to a local overload condition.Does the review identify any patient related factors that contributed to the event? - none evident, partly due to lack of relevant information.Does the review identify any device related factors that caused or contributed to the adverse event? - no device-related factors are associated with any of the implanted devices, consistent with the reported failure mode.-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 lot referenced.Conclusion: a review of the provided medical records and x-rays by a clinical consultant indicated: resorption of a local bone graft at the interface of lateral femoral condylar mrh flange and local femoral bone has resulted in loss of bone support with fatigue accumulation in the lateral mrh and ultimately a femoral mrh device fracture at exactly the location of peak overload requiring a third revision with quite likely a femoral gmrs device and cone augment.No details or results of this third revision procedure are known at this time.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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