Model Number 5450-50-501 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 09/22/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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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The patient was revised to address pain, mid-flexion instability and tightness in flexion.Pathology confirmed that there was no infection.All components were removed and replaced with attune revision crs with sleeves and stems.After removal of components, the surgeon confirmed that nothing was loose.Doi: (b)(6) 2018, dor: (b)(6) 2020, right knee.
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information 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.H10 additional narrative: details for gentamicin component of combination product: dmf# : 13704 trade name : gentamicin sulphate active ingredient(s) : gentamicin sulphate dosage form - powder strength : 1.0g active in our cements.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 = no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
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Search Alerts/Recalls
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