Catalog Number 124150025 |
Device Problem
Naturally Worn (2988)
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Patient Problem
Pain (1994)
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Event Date 01/01/2024 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).E3: the initial reporter information has been removed for confidentiality/privacy.The initial reporter is a patient.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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Patient initiated complaint: during the conversation the patient informed employee that he has been experiencing some pain again to his hip and consulted the doctor recently and has been recommended- a revision surgery due to some wear on poly liner.Since his first hip surgery in (b)(6) 2009 , the doctor is unsure if he can avail the same liner.Patient also mentioned, his implant is from j&j, he brought it to employee attention to check if the product is still available in the market.
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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.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product part#124150025/ lot#2903824 combination.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 a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product part#124150025/ lot#2903824 combination.Added.
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Search Alerts/Recalls
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