Catalog Number UNK HIP FEMORAL HEAD METAL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994)
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Event Date 03/15/2024 |
Event Type
Injury
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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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Event Description
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Voluntary report (mw5153031) received revised total hip arthroplasty due to painful loosening.Discovered evidence of metallosis.Depuy srom stem ceramic cup, polyethylene liner, pinnacle acetabular cup.Failed tha only 3.5 years old due to metallosis.
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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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An email was received, from the patient.It stated, that the implant caused metallosis.Proven by a hip revision surgery.Brown/black fluid pulled from joint space.This caused stem loosening.The implant didn¿t even make it to it's 4th year.
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Search Alerts/Recalls
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