Catalog Number 856744 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Joint Dislocation (2374)
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Event Date 03/25/2022 |
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 on (b)(6) 2019, the patient underwent a bha surgery at another hospital.After surgery, on unknown date, the patient visited (b)(6) hospital complaining of pain of the hip joint, and subluxation was found.The surgeon commented that since infection did not occur, subluxation might be caused by age-related deformation of acetabular.On (b)(6) 2022, the revision surgery was performed.In the revision surgery, the implants in question were removed and tha was performed using zimmer biomet¿s implants.The revision surgery was completed successfully with no surgical delay.No further information is available.Doi: (b)(6) 2019.Dor: (b)(6) 2022.Unknown hip.
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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: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.
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Search Alerts/Recalls
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