Catalog Number UNK HIP INSTRUMENTS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Not Applicable (3189)
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Event Date 06/17/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (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 the patient on hana table for a left direct anterior approach (daa) total hip replacement (thr).The surgeon perforated left proximal femur at the level of the lesser trochanter with a trilock broach.The surgeon switched to summit to bypass the fracture.Threaded inserted used to impact stem.Tip of inserter sheared off in top of stem.Stem remained in place.Head ball applied to stem trunion and hip reduced.Threaded fragment cold welded into stem.10 minutes surgical delay.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary = > the instrument associated with this report was not returned.The root cause could not be determined.Depuy considers the investigation closed at this time.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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