Catalog Number UNK REAMER |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/15/2024 |
Event Type
malfunction
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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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It was reported that while performing a revision knee fusion on the patient, the surgeon removed the old cemented component and decided to implant a press fit component.After removing all traces of the previously implanted cement, the surgeon reamed the femoral canal first with flexible im reamers to the desired size, 15mm.Then, the surgeon reamed with sequential aml straight reamers.Because the patient had less than desired bone density, the surgeon choose to ream line to line of the implant size chosen.The surgeon reamed to a 15.5 and choose to implant a 15.5x125mm stem.Here is the problem, the surgeon was able to stick the component in and pull it out easily with his finger.Stem, 16.5mm, was implanted properly.Because this component fit properly, the surgeon was able to proceed and lock the tibial and femoral component together with new intracalry section and segmental components.It was also reported that there was non-cemented loosening of the lps 15.5 porous stem.Surgical delay was unknown.Doe: (b)(6) 2024 affected side: right knee.
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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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