Medical records received 17 june 2019 and were reviewed 07 october 2019 for mdr reportability.On (b)(6) 2009, the patient underwent total left knee arthroplasty due to degenerative arthritis.The patella was resurfaced.The surgeon reported no intraoperative complications.The patient was implanted with the depuy knee system and unknown cement.On (b)(6) 2015, the patient underwent a left knee revision due to loosening of the femoral component arthrofibrosis, swelling, and pain.The surgeon indicated the femoral component was loose and was able to remove it with his hand.He noted a significant amount of osteolysis along the posterior femoral condyles as well as distally which was extracted.The patellar component was found to be well-fixed and not revised.The surgeon reported the tibial component was well-fixed and retained.The patient was implanted with depuy knee system.Competitor¿s cement was utilized, and there were no complications reported.Doi: (b)(6) 2009; dor: (b)(6) 2015 (lt knee).
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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: the device associated with this report was not 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, a follow-up medwatch will be filed as appropriate.
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