Catalog Number 150410202 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/01/2023 |
Event Type
Injury
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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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Event Description
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It was reported that on (b)(6) 2022, the patient underwent the primary surgery via tka for oa for the right knee joint with the implants in question.On (b)(6) 2023, it was confirmed that there was a strange noise near the patella in the anterior region.Therefore, on (b)(6) 2024, only patella replacement was performed.Since a primary tka of the left side was also scheduled to be performed in this surgery, the left side was performed first and was completed without problems.Subsequently, a procedure was performed to replace the patera (29mm:151820029) on the right side and reduce the thickness of the pf.Pf tracking after replacement was relatively good.
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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 performed.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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