Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.(b)(4).
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It was reported that on literature review "removal of antibiotic cement-coated interlocking nails", one (1) patient suffered from loosening and was indicated for removal or exchange of the interlocking nailing system.The primary trigen interlocking nailing system was implanted with a coating of antibiotic cement and the potential to be permanent (off-label use of the implant).The current state of health of the patient is unknown.No further information is available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the attached literature review on "removal of antibiotic cement-coated interlocking nails", was reviewed.It should be noted, the primary trigen interlocking nailing system was implanted with a coating of antibiotic cement and the potential to be permanent is an off-label use of the implant.However, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The photos provided in the article have been interpreted within the text; therefore, no further analysis of the photos is required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded.No further medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, lack of ingrowth, osteolysis, traumatic injury and/or user error.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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