STRYKER ORTHOPAEDICS-MAHWAH RESTORATION ADM X3 INS 28/52; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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Catalog Number 1236-2-852 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Pain (1994)
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Event Date 02/10/2014 |
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.
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Event Description
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Patient called regarding a hip replacement done on (b)(6) 2014.Patient reported pain.
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Manufacturer Narrative
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An event regarding pain involving an adm liner was reported.The event was not confirmed.Method & results -product evaluation and results: not performed as no product was returned for evaluation the reported device remains implanted.-medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there has been no other similar event for the lot referenced.Conclusion: the event of pain could not be confirmed.Further information such as primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components are required to complete the investigation for determining a root cause.It is noted that a recall query was made regarding the product reported in this event.Based on the catalog and lot number provided the product reported was not subject to a call.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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Patient called regarding a hip replacement done on (b)(6) 2014.Patient reported pain.Spoke to patient, he wants to know if his implants are involved in a recall before he provides additional records.
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Search Alerts/Recalls
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