Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Separation Problem (4043)
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Patient Problem
Not Applicable (3189)
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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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The primary surgery was performed for 18 years ago (date of primary surgery was unknown).The head was dissociated due to breakage of the liner and the locking.It was reported that the revision surgery was scheduled to be performed on (b)(6) 2018 by replacing the stem, the cup, the head, the liner and the locking ring.The surgeon decided to revise the stem due to the surgeon¿s judgement.No further information was provided by the hospital.
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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.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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