Catalog Number UNK HIP FEMORAL HEAD CERAMIC |
Device Problem
Noise, Audible (3273)
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Patient Problems
Pain (1994); Discomfort (2330)
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Event Date 01/01/2019 |
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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Health canada external reference incident id: (b)(4).In (b)(6) 2015 the complainant had a total hip replacement and is now suffering from pain, popping, squeaking and grinding noises that are extremely loud.The issue first surfaced in 2019 approx.And the complainant was able to make the noises go away with exercise.The complainant was considering a revision surgery in 2020 when it was cancelled due to covid and at the same time, the issues seemed to have resolved.A couple of months ago, the complainant started feeling discomfort and the squeaking came back louder than ever.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification 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.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.
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Search Alerts/Recalls
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