Model Number 5450-32-500 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Fall (1848); Pain (1994); Joint Disorder (2373); No Code Available (3191)
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Event Date 02/01/2018 |
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.(b)(4).Initial reporter occupation: attorney.
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Event Description
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Patient fell 6-7 months post-op with increasing pain a few months after the fall.X-rays and bone scan showed loosening and mechanical failure of tibial baseplate as well as subsidence of the baseplate medially with the component in significant varus.Failure also noted at the cement to bone interface laterally.A revision was completed on (b)(6) 2018 using a competitor implants, explanting the depuy femoral component, tibial baseplate, and poly insert, as well as an unknown tibial screw.
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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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Manufacturer Narrative
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(b)(4) used to capture medical device removal.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.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative: added: d6, h6 (patient).Corrected: b1, b2, d3, g1 (physical manufacturer).
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Search Alerts/Recalls
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