Catalog Number UNK HIP FEMORAL STEM |
Device Problems
Degraded (1153); Device Dislodged or Dislocated (2923)
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Patient Problems
Ambulation Difficulties (2544); No Code Available (3191)
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Event Date 06/02/2020 |
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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The primary surgery was performed on an unknown date.It was reported that the patient had difficulty in walking because the head (p/n: 152190060) popped out of the neck.The revision surgery was performed on (b)(6) 2020 by replacing the head and the cup (p/n: unknown).In view of the head¿s popping out of the neck, there was a suspicion of corrosion.The revision surgery was completed, and it was unknown whether there was any surgical delay.No further information is available.
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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.H10 additional narrative: added h6(device).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: no device associated with this report was received for examination.A photograph of the head was provided for investigation.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.
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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.A photograph of the head was provided for investigation.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.
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Search Alerts/Recalls
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