Model Number 1518-10-035 |
Device Problems
Failure To Adhere Or Bond (1031); Naturally Worn (2988)
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Patient Problems
Muscular Rigidity (1968); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 09/25/2017 |
Event Type
Injury
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Manufacturer Narrative
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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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On 20 apr 2018 medical records received.After review of the medical records for mdr reportability, the patient was revised (b)(6) 2017 to address left knee aseptic failure.During the surgery notes, the surgeon reported that there was debonding of the cement to the tibial component, patella polywear, and stiffness.Competitor components were placed during the revision.Doi: (b)(6) 2017; dor: (b)(6) 2017; (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.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.Device history lot: null.Device history batch: null.Device history review: null.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: h6 patient code: no code available (3191) was used to capture medical device removal and surgical intervention.
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Search Alerts/Recalls
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