Catalog Number 150411126 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Fall (1848); Unspecified Infection (1930)
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Event Date 07/17/2023 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).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.Device was used for treatment, not diagnosis.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 underwent an attune rpps construct on (b)(6) 2023.She received a pressfit ps femur, cemented rp tibia, rpps insert, 35 anatomic patella.Unfortunately, she experienced a fall 2 weeks ago.It was noted that she dehisced her surgical closure.It is suspected this is how she became infected.Upon opening of the knee for the washout on monday (b)(6) 2023, she drained pus and was confirmed for infection.All parts and pieces were removed and a cement spacer was implanted to treat the confirmed infection.Doi: (b)(6) 2023.Dor: (b)(6) 2023.Affected side: left knee.
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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 information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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