Model Number 3L92501 |
Device Problems
Loss of or Failure to Bond (1068); Loss of Osseointegration (2408); Unintended Movement (3026); Migration (4003)
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Patient Problems
Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 06/19/2020 |
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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Post-op stem sink down.It was reported that the patient was given the half hip replacement, operation on (b)(6) 2020.One week later, before discharged from the hospital, took x-ray, noted the stem was loose, sank down.The patient was given revision operation on (b)(6) 2020.The patient is stable and in hospital now.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: visual examination of the returned stem finds nothing outward to suggest product error.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.Device history lot: lot 5357628.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Device history review: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
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Search Alerts/Recalls
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