STRYKER ORTHOPAEDICS-MAHWAH SCORPIO NRG X3 CR TIBIAL INSERT #7 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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Catalog Number 82-6-0710 |
Device Problems
Degraded (1153); Naturally Worn (2988)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/18/2023 |
Event Type
Injury
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Event Description
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Revision knee.Left scorpio nrg cr x3.Operation was poly change, for wear.Size 8l femur.Size 7 tibia.7-10mm nrg cr x3 poly.Surgeon would like the wear on the cr x3 poly investigated.Medial side in particular, deeper white area.
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Manufacturer Narrative
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Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.H3 other text : not returned to the manufacturer.
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Event Description
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Revision knee.Left scorpio nrg cr x3.Operation was poly change, for wear.Size 8l femur.Size 7 tibia.7-10mm nrg cr x3 poly.Surgeon would like the wear on the cr x3 poly investigated.Medial side in particular, deeper white area.
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Manufacturer Narrative
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Reported event an event regarding wear involving a scorpio insert was reported.The event was confirmed.Method & results -product evaluation and results: visual inspection: damage consistent with the explantation process was observed on the anterior surface of the implant.Burnishing, scratching, delamination, and third body indentations were observed on the articulating surface which are common damage modes of uhmwpe.The aforementioned damage modes are consistent with contact against the femoral component.Yellow discoloration consistent with the absorption of synovial fluid was also observed.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar evets for lot referenced.Conclusions: it was reported that the patient was revised due to insert wear.Visual inspection: damage consistent with the explantation process was observed on the anterior surface of the implant.Burnishing, scratching, delamination, and third body indentations were observed on the articulating surface which are common damage modes of uhmwpe.The aforementioned damage modes are consistent with contact against the femoral component.Yellow discoloration consistent with the absorption of synovial fluid was also observed.Based on the given information no materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
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Search Alerts/Recalls
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