Catalog Number 6191-1-001 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Injury (2348)
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Event Date 08/17/2016 |
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There has been one other event for the lot referenced.Not returned.
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Event Description
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As per received medical records: "closed reduction, right hip, mold." patient was implanted with competitor and stryker cement on (b)(6) 2016.
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Event Description
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As per received medical records: "closed reduction, right hip, mold." patient was implanted with competitor and stryker cement on (b)(6) 2016.
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Manufacturer Narrative
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An event regarding dislocation involving a simplex cement was reported.Conclusions: based on the provided information, the product reported in this investigation did not contribute to the event as the dislocation occurred between the uhr head cement mold and the acetabulum.The cement was used to fill the mold and cement the stem proximally.No allegations were made against the reported device.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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