Model Number 1221-40-058 |
Device Problem
Off-Label Use (1494)
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Patient Problems
Unspecified Infection (1930); No Code Available (3191)
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Event Date 05/18/2020 |
Event Type
Injury
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Manufacturer Narrative
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(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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It was reported that patient had a rt tha performed on (b)(6) 2019.The surgeon stated that the patient got an infection and he needed to do a head and liner exchange.The stem the patient has in is a medacta cemented stem, so he only needed the pinnacle liner.The surgeon removed the head and liner, did an i&d, and put in stimulan beads, and then the new liner and head.Doi: (b)(6) 2019.Dor: (b)(6) 2020.Affected side: right hip.
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Manufacturer Narrative
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Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
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Search Alerts/Recalls
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