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Catalog Number 545032500 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Pain (1994); No Code Available (3191)
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Event Date 11/19/2019 |
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.
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Event Description
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Patient was revised to address pain and loosening of the tibial baseplate at the cement to implant interface.Depuy cement manufacturer was used.Patient presented with anterior tibial knee pain to the surgeon and has been unpleased with the primary prosthesis since original placement.Surgeon determined tibial baseplate was likely loose based off of pre-operative images.It was determined intra-operatively that the tibial baseplate was likely aseptically loose, however it took several minutes to remove the baseplate from the tibia bone.Baseplate appeared wet and fatty from micro-lipid infiltration between the implant and cement.Tibia baseplate did not have cement attached to the prosthesis.Surgeon decided to revise the femur, tibia and insert to attune revision to achieve a higher level of stability.Neither the femur nor patella showed signs of loosening.Patient requested for primary attune implants be collected for potential litigation.Doi: (b)(6) 2016; dor: (b)(6) 2019; 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 = > 8283423.Device history review = > the dhr review revealed of the (b)(4) batch, one unrelated non-conformance of this lot was identified.Final micro and sterility tests passed.There were no anomalies identified on this lot.If information is obtained that was not available for the initial medwatch, a follow-up 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.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.Device history lot = > 8283423.Device history review the dhr review revealed of the 1140-unit batch, one unrelated non-conformance of this lot was identified.Final micro and sterility tests passed.There were no anomalies identified on this lot.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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