Catalog Number 121828648 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 02/04/2024 |
Event Type
Injury
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Event Description
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Patient's primary surgery was done on the (b)(6) 2018 by dr.(b)(6).She the returned for a revision on the dr.(b)(6) who increased her pinnacle cup size and put in a constrained liner.This patient then presented to (b)(6) 2024 with a hip infection.The patient had an irrigation and debridement (i&d), poly and head exchange.An additional case (b)(4) is logged to capture the previous revision happened on (b)(6) 2020.
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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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Event Description
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Please confirm why the revision surgery was performed.-thought the patient may have been infected, but not physical evidence seen, multiple specimens taken.Was infection confirmed for both revisions ? i was not present at the first revision, but i would assume she was dislocating and i am also unaware of the specimen results, but again i would assume it was as puss was seen.
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Search Alerts/Recalls
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