Catalog Number 64951201 |
Device Problems
Device Operates Differently Than Expected (2913); Device-Device Incompatibility (2919)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 06/05/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.
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Event Description
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Company rep reported that during trialing the implant and trial did not match.Surgeon opened another implant and completed surgery successfully.
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Manufacturer Narrative
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An event regarding incorrect selection involving a gmrs proximal femoral component was reported.The event was confirmed.Device evaluation and results:the gmrs prox fem standard right was returned for evaluation.The device was inspected against its product drawing and it was confirmed to be a right proximal femoral component as per product identification.The returned device appears unremarkable.Medical records received and evaluation: x-rays were provided in relation to cross reference pi only.No medical records were provided in relation to the reported event regarding incorrect selection of the gmrs proximal femoral component.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the reported lot referenced.Conclusions: the x-rays provided were of a left knee with femur and hip.The patient labels provided of the devices for implantation confirms that the connection piece was for a left side.The gmrs proximal femoral component the surgeon tried to implant was for a right side.Using the right proximal femoral would dictate the orientation of the component and thus rotate the femur into internal rotation.Based on the information provided it appears that the gmrs right proximal femoral component was wrongly selected for use on a left side.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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Event Description
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Company rep reported that during trailing the implant and trial did not match.Surgeon opened another implant and completed surgery successfully.The surgeon stated that the trials had rotated the femur into external rotation but the real implant had pushed it into internal rotation.
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Search Alerts/Recalls
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