Model Number 542-11-58G |
Device Problem
Malposition of Device (2616)
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Patient Problem
Pain (1994)
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Event Date 05/12/2014 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Should additional information become available, 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 relevant reported discrepancies.There has been 1 similar event for the lot referenced.Device not returned to the manufacturer.
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Event Description
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As per records received, "according to the (b)(6) 2019 revision operative report, he had persistent pain and was revised 5 years ago.At surgery his acetabular component was found to be in retroversion.A new stryker acetabular component was placed along with new stryker head on his accolade stem.".
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Should additional information become available, 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 relevant reported discrepancies.There has been 1 similar event for the lot referenced.
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Event Description
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As per records received, "according to the (b)(6) 2019 revision operative report, he had persistent pain and was revised 5 years ago.At surgery his acetabular component was found to be in retroversion.A new stryker acetabular component was placed along with new stryker head on his accolade stem.".
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Search Alerts/Recalls
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