Catalog Number 626-00-42E |
Device Problems
Material Disintegration (1177); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
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Patient Problems
Pain (1994); Injury (2348)
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Event Date 05/19/2017 |
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 no other similar 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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Revision of a mobile dual mobility (mdm) liner due to disassociation of the metal head with the polyethylene liner.Noticed radiologically after patient experienced pain and noise on mobility.
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Manufacturer Narrative
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An event regarding dislocation involving an adm liner & metal head was reported.Conclusion: based on the provided information, the product reported in this investigation did not contribute to the event.The event was reported for dislocation and there is no allegation or evidence of failure against the mdm liner.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted for this product, this record will be reopened.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product nonconformity or unanticipated hazard.
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Event Description
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Revision of a mobile dual mobility (mdm) liner due to disassociation of the metal head with the polyethylene liner.Noticed radiologically after patient experienced pain and noise on mobility.Additional information: a review by a clinical consultant identified an unknown exter stem malposition in excessive anteversion the most likely cause of the recurring dislocations.
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Search Alerts/Recalls
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