Model Number 62-3401R |
Device Problems
Loss of or Failure to Bond (1068); Device Dislodged or Dislocated (2923)
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Patient Problems
Fall (1848); Unspecified Infection (1930); Pain (1994); Joint Laxity (4526)
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Event Date 11/01/2022 |
Event Type
Injury
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Event Description
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Revision completed due to patient falling on his knee.Upon exposure to the joint space it was discovered that medium srom hinged femur had loosened away from the porous femoral sleeve construct.The loosening occurred at the taper point of the femur to the sleeve.Surgeon removed the still engaged hinged pin with a pair of kochers and then removed the medium x 26mm poly with his hand and then removed the medium right femur by hand.Upon further examination the surgeon stated that none of the implants had broken or shown unusual wear but had simply disengaged as a result of the fall the patient experience.The tibial component and femoral sleeve/stem were well fixed.Doi: unknown; dor: (b)(6) 2022; affected side: right knee.
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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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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 623401r, lot - j5925n, and no non-conformances / manufacturing irregularities were identified.
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Search Alerts/Recalls
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