Catalog Number 550515 |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616)
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Patient Problem
Pain (1994)
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Event Date 04/20/2017 |
Event Type
Injury
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Manufacturer Narrative
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This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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The patient was revised to address query infection.It was reported that the stem was undersized and in varus and patient also experienced pain.
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Manufacturer Narrative
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The complaint states the patient was revised to address query infection.It was reported that the stem was undersized and in varus and patient also experienced pain.A review of complaint databases ore review of manufacturing records could not be conducted as no product details were received.The x-rays were reviewed as per (b)(4).No implant fracture or disassociation was identified.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Post market surveillance is per (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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