Model Number 96-0781 |
Device Problem
Fracture (1260)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 12/09/2022 |
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.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 due to loosening of the unknown component at the unknown interface.Cement manufacturer was unknown.It was also reported that the patient broke the adaptor and adaptor bolt for the second time.Bone has resorbed around the implant creating almost a distal femoral replacement situation.Adaptor bolt, adaptor, femoral component and insert were removed leaving the tibial component and femoral sleeve and stem well fixed in the patient.A hinged component was then prepped for and impacted into the sleeve that was well fixed in the bone and a lps insert was inserted.Doi: (b)(6) 2017.Dor: (b)(6) 2022.Right 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 a manufacturing record evaluation (nc search) was performed for the finished device product code:960781, lot -h69628 and no non-conformances / manufacturing irregularities were identified.
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Search Alerts/Recalls
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