Catalog Number UNK ATTUNE KNEE TIBIAL TRAY |
Device Problems
Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
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Patient Problem
Pain (1994)
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Event Date 01/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Initial reporter occupation: lawyer.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that the patient experienced polyethylene loosening occurred in the affected patient approximately 2 to 3 months after the implantation.It was found in the report that this loosening was caused by a mistake made by the surgeon during the implantation.
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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.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 : the device was not returned to depuy synthes for evaluation, however photos were provided for review.Review of the provided photos confirmed the disassociation event.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a positive identification of the unknown tibial tray product information was not visible from the photos provided.A manufacturing records evaluation (mre) was not performed as no lot number was provided or could be obtained from the photos of this device.Device history review : a positive identification of the unknown tibial tray product information was not visible from the photos provided.A manufacturing records evaluation (mre) was not performed as no lot number was provided or could be obtained from the photos of this device.
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Search Alerts/Recalls
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