Catalog Number 198713111 |
Device Problems
Loss of or Failure to Bond (1068); Osseointegration Problem (3003)
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Patient Problems
Fall (1848); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); Insufficient Information (4580)
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Event Date 06/02/2017 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (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 due to aseptic loosening.Doi: unknown.Dor: (b)(6) 2021, unknown knee side.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified 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.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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Event Description
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Medical records were reviewed and indicated the following: clinic notes prior to revision report the following: (b)(6) 2016: patient fell with increased pain ¿ no intervention.(b)(6) 2016: patient has more pain, radiolucent lines unchanged around femoral.(b)(6) 2017: increasing pain, patient is now unable to ambulate.(b)(6) 2017: patient is revised for septic loosening of the femoral component-interface not mentioned with dense scar tissue found.The lps distal femur replacement, segmental component, sleeve adaptor, femoral sleeve, tibial hinge insert, and universal stem are revised.The tibial components are not revised.Operative side: left.Height: 176cm.
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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.All available x-rays were reviewed, there is no sufficient evidence in order to confirm the complaint.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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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