Model Number 1506-10-006 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Pain (1994); Injury (2348); Deformity/ Disfigurement (2360); Not Applicable (3189); No Code Available (3191)
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Event Date 10/24/2016 |
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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Attune claim letter record received.Claim letter alleges injury, pain, disfigurement and attune tibial base loosening, debonded at cement implant interface.Cement manufacturer used was unknown.Doi: (b)(6) 2015; dor: (b)(6) 2016; right 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 at this time.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.(no code available (3191) is used to capture the surgical intervention and 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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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.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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 : a device history record (dhr) review was performed on (b)(4).Product code 150610006, work order (b)(4) was manufactured on 28-aug-2015.(b)(4) parts were manufactured per specification and all raw materials met specification.There were no ncs or deviations associated with this lot.Review of the dhrs did not reveal any related manufacturing deviations or anomalies on the provided product and lot combination.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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Search Alerts/Recalls
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