Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Joint Dislocation (2374); Impaired Healing (2378)
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Event Date 11/01/2022 |
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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The published article ¿study of the clinical efficacy of corail femoral prostheses of different eccentricity in total medullary joint replacement¿ by li peng, xiong changjun, du yinqiao, dong yu, gao zhisen, li tiejian, and zhou yonggang published on november 2022 in the chinese journal of orthopeadic trauma was reviewed for adverse events.The purpose of the article was to evaluate the clinical efficacy of standard vs high offset corail femoral stems by analyzing postoperative xrays.There is no indication the manufacturer of the cup/liner on the acetabular side.Of 186 patients, the following complications occurred: one intraoperative femoral fracture fixated with a cable.One wound malhealing.One case of dislocation requiring reoperation.
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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.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.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 device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.
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Search Alerts/Recalls
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