Catalog Number UNK HIP |
Device Problem
Osseointegration Problem (3003)
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Patient Problems
Foreign Body Reaction (1868); Inadequate Osseointegration (2646)
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Event Date 02/18/2022 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that on an unknown date, the patient underwent the surgery due to unknown reason with the implants in question.After the surgery, on (b)(6) 2022, the patient underwent the revision surgery for removing implants due to loosening and metallosis.The revision surgery was completed successfully without any surgical delay.No further information is available.Doi: unknown, dor: (b)(6) 2022, unknown side.
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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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