Model Number 1365-32-310 |
Device Problems
Naturally Worn (2988); Noise, Audible (3273)
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Patient Problems
Adhesion(s) (1695); Foreign Body Reaction (1868)
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Event Date 12/15/2020 |
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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Primary operative notes (b)(6) 2015 indicate the patient received a right total hip replacement due to end stage osteoarthritis.The surgery was completed without indication of complication by the surgeon.Revision operative notes (b)(6) 2020 indicate the patient received a right total hip revision of the head and liner due to hip squeaking and polyethylene liner wear.Upon entering the joint, blackened tissue and adhesions were encountered and removed.The femoral head shows considerable black stripe wear from contact with the cup through the worn liner.The surgery was completed without indication of complication by the surgeon.It should be noted that the patient has also received a left total hip with left hip revision.However, at the time of this review, it is unknown if the left hip components are depuy.
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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 : examination of the returned device and provided images found evidence to support the reported implant noise.This device was manufactured on 19-dec-2014.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot : the component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of any pre-existing material defect.
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Search Alerts/Recalls
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