Catalog Number 257004501 |
Device Problems
Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/22/2019 |
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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Total hip replacement: the surgeon used the new mi clacar plating tool, without applying any pressure when planning and the patient obtained a calcar fracture.Calcar was assessed to see if cabling was required.No ae reported, no delay in the surgery.Patient initial: (b)(6).
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary = > examination of the returned instrument could not confirm the reported observation.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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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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Search Alerts/Recalls
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