Catalog Number UNK HIP ACETABULAR LINER CERAM |
Device Problem
Fracture (1260)
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Patient Problem
Pain (1994)
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Event Date 12/09/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient had an mri, and the result was a ceramic breakage.Fragments of the porcelain floated in his hip and caused excruciating pain.On friday (b)(6) 2022, the patient had an emergency surgery.The specialist renewed the liner and the head.New head : biolox delta 52mm + 1.5.Removed: the implant : cup : pinnacle size 52 mm.Liner : biolox delta ceramax 52mm 00/36 mm id stem : trilock size 5 head : biolox delta 36 mm product code and lot numbers are unknown!!.
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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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Search Alerts/Recalls
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