Catalog Number 64951001 |
Device Problem
Device Packaging Compromised (2916)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
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Event Description
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It was reported that while performing a procedure on patient's knee (side not reported), implant appeared to have been repackaged.The outer seal was compromised.Upon inspection of the inner seal, it was found to have been compromised.The surgeon refused use of the implant due to sterility concerns.An alternative implant was available in approximately 2 minutes.The procedure was completed successfully otherwise.
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Manufacturer Narrative
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Device not returned.Product available to stryker.An event regarding packaging damage involving a gmrs femoral component was reported.The event was not confirmed.Device evaluation and results: not performed as no product was returned for evaluation.Medical records received and evaluation: not performed as the event is related to a packaging issue.Indicated all devices were manufactured and accepted into final stock on with no reported discrepancies.There have been no other similar events for the lot referenced.As no product was returned or no photographs provided the reported event could not be confirmed.Further information such as all packaging return including the outer blister and unit carton is required to complete the investigation for determining a root cause.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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It was reported that while performing a procedure on patient's knee (side not reported), implant appeared to have been repackaged.The outer seal was compromised.Upon inspection of the inner seal, it was found to have been compromised.The surgeon refused use of the implant due to sterility concerns.An alternative implant was available in approximately 2 minutes.The procedure was completed successfully otherwise.
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Search Alerts/Recalls
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