Catalog Number 124108000 |
Device Problem
Naturally Worn (2988)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/26/2024 |
Event Type
Injury
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Event Description
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This pc is related to (b)(4) which reports revision surgery for stem.This pc reports revision surgery for liner.It was reported that on an unknown date (16 years ago), the patient underwent the primary surgery with stem and liner in question at another hospital.On an unknown date, it was confirmed that the stem had sunk.Therefore, the stem was replaced with a stem made by another company on (b)(6) 2024.During the surgery, the liner was also replaced due to be age-related deterioration of the liner.No further information is available.
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Manufacturer Narrative
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Product complaint # (b)(4).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.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not perform 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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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