Model Number 5450-50-501 |
Device Problems
Loss of or Failure to Bond (1068); Loss of Osseointegration (2408)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 07/10/2017 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.(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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Medical records received: 23 jul 2018.Medical records reviewed for mdr reportability.Patient underwent a left tka and the tibial tray and insert were later revised for start-up pain and mid stance laxity.Intraoperative findings included decreased range of motion and loosening of the tibial tray at cement to implant and cement to bone interfaces.Surgeon mentions the previous tibial tray had a 2mm overhang from the anterior/medial tibia.Doi: (b)(6) 2016; dor: (b)(6) 2017, (tray and insert only).
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Manufacturer Narrative
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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. added:initial reporter name and address,other relevant history,evaluation codes(patient codes).Corrected:age ,date of 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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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Additional narrative: 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.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).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. corrected: h6 (no code available (3191) is used to capture the device revision or replacement).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: h6 (patient) corrected: d2b, d3, g1, g2 h6 (device code) the reported loss of osseointegration code is being retracted.
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Search Alerts/Recalls
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