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Model Number 55-6073 |
Device Problems
Fracture (1260); Off-Label Use (1494); Osseointegration Problem (3003)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Inadequate Osseointegration (2646)
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Event Date 05/23/2022 |
Event Type
Injury
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Event Description
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It was reported that on (b)(6) 2007, the patient underwent a tha surgery for oa of hip.After surgery, the screws broke due to loosening of a cup, and the patient had pain.On (b)(6) 2022, a revision surgery was performed with no surgical delay.In the revision surgery, the stem was kept using as it was, and the cup was replaced.The loosened cup is a competitor¿s product.The surgeon commented that the cause of loosening of the cup might have been due to alval (aseptic lymphocytic vasculitis-related lesion) since the implants implanted in a state of mom.No further information is available.
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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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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: d10 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: g1.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : device associated with this report was not received for examination.All available x-rays and photographs were reviewed.The screw has fractured at the threaded portion.The screw was used off label use with a competitor cup.Implant loosening cannot be confirmed without a series of x-rays images.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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