Catalog Number 61971001 |
Device Problems
Insufficient Information (3190); Migration (4003)
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Patient Problems
Injury (2348); Ambulation Difficulties (2544)
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Event Date 12/13/2019 |
Event Type
Injury
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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 two other similar events for the lot referenced.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.Device not returned.
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Event Description
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A 44 no 2 exeter stem was revised due to subsidence.The surgeon stated it was not a failure of the implant, but that the bone / cement interface had failed, causing both the stem and cement mantle to subside.Surgeon was unable to provide details of primary surgery.
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Event Description
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A 44 no 2 exeter stem was revised due to subsidence.The surgeon stated it was not a failure of the implant, but that the bone/cement interface had failed, causing both the stem and cement mantle to subside.Surgeon was unable to provide details of primary surgery.
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Manufacturer Narrative
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An event regarding subsidence of a stem involving simplex cement mix was reported.The event was confirmed through clinician review of the provided x-ray.Method & results: device evaluation and results: not performed as no product was returned for evaluation.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: first revision on (b)(6) 2014 for reported subsidence was not confirmed however, x-ray provided confirms revision on (b)(6) 2019 was due to subsided stem, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.Device history review: indicated all ten packs were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been two other similar events for the lot referenced.The events relate to the same patient and are within this pi, therefore no additional trending is required.Conclusion: the event of subsidence was confirmed through clinician review of the provided x-ray.The exact cause of the event cannot be confirmed as insufficient information was provided.Additional information such as primary and revision operative reports, clinical and past medical history and additional serial dated x-rays are required to complete the investigation and determine a root cause.No further investigation for this event is possible at this time.If devices and / or 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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