Model Number PHA01242 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Unequal Limb Length (4534)
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Event Date 01/19/2022 |
Event Type
Injury
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Event Description
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Allegedly, the neck and head were replaced for leg length correction.Additionally, re-substitution of cup due to loosening of another company's cup.Mpo's tl size 1 stem side was fine.(b)(4).
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Manufacturer Narrative
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This event will be updated once the investigation is complete.Trends will be evaluated.
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Manufacturer Narrative
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This event will be updated once the investigation is complete.Trends will be evaluated.
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Event Description
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Allegedly, the neck and head were replaced for leg length correction.Additionally, re-substitution of cup due to loosening of another company's cup.Mpo's tl size 1 stem side was fine.(b)(4).
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Manufacturer Narrative
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Additional information received on 03/11/2021 : no longer reportable, as indicated by mah on march 11th, because the information was clarified by the mah with pmda.The cup had loosening but the manufacturer is another company.There is no alleged deficiency against the neck and head, please void the following report.
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Search Alerts/Recalls
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