Catalog Number UNK HIP ACETABULAR LINER |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Scar Tissue (2060); Joint Dislocation (2374); Unspecified Tissue Injury (4559)
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Event Date 01/03/2024 |
Event Type
Injury
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Event Description
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Subject id: (b)(6), study no: dots.Clinical notification received.For revision, due to dislocation.Date of implant: unk, date of revision: (b)(6) 2024, (right hip).Treatment: head and liner revised.Were depuy components removed? yes.
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Manufacturer Narrative
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Product complaint (b)(4).D4: the device catalog number is unknown.Therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot :the device lot number is unknown, therefore a¿device history review could not be performed.¿ if the lot/serial number becomes available, the record will be re-assessed.
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Event Description
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Additional information received: on (b)(6) 2024, the patient was revised to address posterior dislocation of right hip.Components implanted included: depuy pinnacle dual mobility metal liner, a bi-mentum polyethylene liner, femoral ball.The surgeon observed extensive scarring.There was a fragment of bone seen on ct scan of uncertain origin which was removed posteroinferiorly.There were noted to have no complications.
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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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Search Alerts/Recalls
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