Model Number PHA01244 |
Device Problem
Break (1069)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/10/2021 |
Event Type
Injury
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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, sudden sagging and cracking of the hip, he could no longer strain.Neck broke.Additional information received on 02/17/2021: exact implanting date received (b)(6) 2009, and confirmation that the stem was not revised.Additional information received on 02/18/2021: lot number for the femoral head.Additional information received on 02/25/2021: incident description, components revised, implantation date (b)(6) 2009 and revision date (b)(6) 2021.Allegedly, the neck fractured.Additional information received on 02/26/2021: product id and lot number for femoral head, moreover confirmation that there were no deficiencies against this component.Component not revised: profemur e+ stem gr 5 product id: pha03165 (b)(6) case number: (b)(4).
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Manufacturer Narrative
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Updated incident description.
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Event Description
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Allegedly, sudden sagging and cracking of the hip, he could no longer strain.Neck broke.Additional information received on 02/17/2021: exact implanting date received (b)(6) 2009, and confirmation that the stem was not revised.Additional information received on 02/18/2021: lot number for the femoral head.Additional information received on 02/25/2021: incident description, confirmation of components revised, implantation and revision date.Allegedly, the neck fractured.Additional information received on 02/26/2021: confirmation of product id and lot number for femoral head, indication that there were no deficiencies against this component.Component not revised: profemur e+ stem gr 5 product id: pha03165.Bfarm case number: (b)(4).
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Search Alerts/Recalls
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